Hernia, Inguinal, Pain, Postoperative
Conditions
Keywords
postoperative pain chronic pain
Brief summary
The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.
Interventions
DRUGPregabalin
150 mg BID
DRUGplacebo
Placebo
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
17 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The subject will have elective ( the subject chooses, but does not have to undergo surgery for an emergency) open unilateral inguinal herniorraphy (hernia repair), using mesh Lichtenstein surgery procedure and under general anesthesia and fentanyl or sufentanil/propofol initiation and sevoflurane or isoflurane maintenance plus local anesthetic infiltration at the conclusion of surgery. Study surgery should be anticipated to be in the morning. * Expected to be able to use and tolerate non-steroidal anti-inflammatory drugs (such as naproxen), tramadol, oxycodone, and acetaminophen/paracetamol for pain control after surgery. * The subject will be available for a visit within 72 hours of the day of surgery if not admitted the night before for baseline assessments before taking any study medication, and then to receive study medication prior to the day before surgery. * The subject is expected and agrees to remain at the hospital (or intermediate care facility) for a minimum of 3 hours following surgery.
Exclusion criteria
* Subjects with non elective or emergency surgery (must have the surgery no matter what), or hernia with incarceration (the trapping of abdominal contents within the hernia itself). * Subjects with hernia repair that is not a primary repair. The planned use of nerve block or spinal/epidural/paravertebral anesthesia or surgery is not planned with general anesthesia. * Subjects that are not allowed to receive the anesthesia agents indicated per protocol and general anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery | 24 hours post surgery | m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination]) | NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain). |
| Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination]) | NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain) |
| Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | 1 hour through 48 hours post surgery | NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain). |
| Numerical Rating Scale (NRS): Current Pain at Rest | 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS | NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain). |
| Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) | 1 through 48 hours post surgery (PS) | NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain). |
| Numeric Rating Scale (NRS): Average Pain | 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS | NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain). |
| Time From End of Surgery to First Rescue Medication | Day 1 through Day 7 post surgery | Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal. |
| Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS) | Day 1 | PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge. |
| Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU) | Day 1 | — |
| Daily Sleep Interference Rating Scale (DSIRS) Score | Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS) | DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep \[unable to sleep due to pain\]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication. |
| Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS | Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent. |
| Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study | End of Surgery through Day 7 post surgery | Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery. |
| Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination]) | NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain). |
| Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | 3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination]) | OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr). |
| Subject Global Evaluation of Study Medication (GESM) | 24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination]) | GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent. |
| Participants With Wound Healing Complications | Day 7 post surgery (PS) and up to 30 days PS | Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication. |
| Participants With Physician Contacts Post-discharge | 24 and 72 hours (h) post surgery (PS) | Number of participants who answered yes to the Post-Surgery Contact question: From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine? |
| Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS | Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws. |
| Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination]) | EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state. |
| Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | 3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination]) | The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing. |
| Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy | Baseline and Days 1 and 7 post surgery (PS) | The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing. |
| Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination]) | PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average. |
| Participants With Chronic Postoperative Pain | 1, 3, and 6 months (mo) post surgery (PS) | Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: In the last 24 hours, have you had pain in the area affected by your surgery?) |
| Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | 1, 3, and 6 months (mo) post surgery (PS) | m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain). |
| Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | 1, 3, and 6 months (mo) post surgery (PS) | NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 \[no pain\] to 10 \[worst pain imaginable\]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain. |
| Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | 3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination]) | OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 \[none\] to 10 \[10 CMEs\]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 \[none\] to 9 \[9 CMEs\]). |
Countries
Australia, Canada, India, Spain, Sweden, United States
Participant flow
Recruitment details
Male subjects were enrolled at 34 centers and participated in the study between 18 January 2008 and 14 September 2009.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin 50 mg Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week. | 108 |
| Pregabalin 150 mg Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week. | 106 |
| Pregabalin 300 mg Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week. | 103 |
| Placebo Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week. | 108 |
| Total | 425 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Other | 3 | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | Pregabalin 300 mg | Pregabalin 150 mg | Pregabalin 50 mg |
|---|---|---|---|---|---|
| Age, Customized >=65 years | 54 participants | 15 participants | 11 participants | 11 participants | 17 participants |
| Age, Customized Between 18 and 44 years | 166 participants | 46 participants | 40 participants | 37 participants | 43 participants |
| Age, Customized Between 45 and 64 years | 205 participants | 47 participants | 52 participants | 58 participants | 48 participants |
| Sex/Gender, Customized | 425 participants | 108 participants | 103 participants | 106 participants | 108 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 46 / 108 | 44 / 106 | 56 / 103 | 45 / 108 |
| serious Total, serious adverse events | 3 / 108 | 1 / 106 | 0 / 103 | 3 / 108 |
Outcome results
Primary
Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).
Time frame: 24 hours post surgery
Population: Modified Intent-to-Treat Population (MITT): all subjects included in intent-to-treat population who took study medication 12 and 2 hours prior to surgery, had no complications during herniorrhaphy, and had the post-surgery primary efficacy measurement. Data from 1 site excluded due to Good Clinical Practices (GCP) deviations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 50 mg | Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery | 5.2 scores on scale | Standard Error 0.24 |
| Pregabalin 150 mg | Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery | 5.4 scores on scale | Standard Error 0.25 |
| Pregabalin 300 mg | Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery | 4.7 scores on scale | Standard Error 0.24 |
| Placebo | Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery | 5.4 scores on scale | Standard Error 0.24 |
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0668ANOVA
Comparison: LS (least squares) means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0334ANOVA
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8003ANOVA
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8003ANOVA
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6932ANOVA
Secondary
Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study
Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.
Time frame: End of Surgery through Day 7 post surgery
Population: MITT; data from 1 site excluded due to GCP deviations. Amount of antiemetic rescue medications not analyzed as planned.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 50 mg | Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study | 3938.81 mg | Standard Error 155.124 |
| Pregabalin 150 mg | Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study | 3930.57 mg | Standard Error 155.304 |
| Pregabalin 300 mg | Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study | 3892.96 mg | Standard Error 154.413 |
| Placebo | Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study | 3770.07 mg | Standard Error 153.322 |
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4177ANOVA
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.441ANOVA
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.556ANOVA
Secondary
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score
Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Baseline (n=101, 98, 100, 100) | 20.2 scores on a scale | Standard Error 2.07 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h BS (n=101, 98, 100, 99) | 0.2 scores on a scale | Standard Error 1.56 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 1 h PS (n=100, 96, 99, 99) | -6.4 scores on a scale | Standard Error 1.71 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h PS (n=101, 98, 100, 100) | -8.4 scores on a scale | Standard Error 1.51 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 3 h PS (n=101, 98, 100, 100) | -8.7 scores on a scale | Standard Error 1.44 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 2 PS (n=101, 98, 100, 100) | -7.9 scores on a scale | Standard Error 1.59 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 3 PS (n=101, 97, 99, 100) | -9.1 scores on a scale | Standard Error 1.23 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 4 PS (n=101, 98, 98, 101) | -11.1 scores on a scale | Standard Error 1.23 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 5 PS (n=101, 98, 97, 99) | -12.3 scores on a scale | Standard Error 1.06 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 6 PS (n=100, 98, 97, 97) | -12.5 scores on a scale | Standard Error 1.08 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 7 PS (n=97, 93, 89, 95) | -13.0 scores on a scale | Standard Error 1.15 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 8 PS (n=61, 64, 53, 58) | -13.6 scores on a scale | Standard Error 1.16 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 9 PS (n=21, 24, 23, 22) | -16.6 scores on a scale | Standard Error 2.07 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h PS (n=101, 98, 100, 100) | -7.6 scores on a scale | Standard Error 1.52 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 9 PS (n=21, 24, 23, 22) | -16.4 scores on a scale | Standard Error 1.9 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 7 PS (n=97, 93, 89, 95) | -15.2 scores on a scale | Standard Error 1.16 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 4 PS (n=101, 98, 98, 101) | -15.3 scores on a scale | Standard Error 1.24 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 1 h PS (n=100, 96, 99, 99) | -3.5 scores on a scale | Standard Error 1.73 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Baseline (n=101, 98, 100, 100) | 19.4 scores on a scale | Standard Error 2.1 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 6 PS (n=100, 98, 97, 97) | -15.0 scores on a scale | Standard Error 1.08 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 5 PS (n=101, 98, 97, 99) | -15.0 scores on a scale | Standard Error 1.07 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 2 PS (n=101, 98, 100, 100) | -10.4 scores on a scale | Standard Error 1.6 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 3 h PS (n=101, 98, 100, 100) | -8.3 scores on a scale | Standard Error 1.45 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h BS (n=101, 98, 100, 99) | 3.2 scores on a scale | Standard Error 1.58 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 8 PS (n=61, 64, 53, 58) | -15.4 scores on a scale | Standard Error 1.11 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 3 PS (n=101, 97, 99, 100) | -12.7 scores on a scale | Standard Error 1.25 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 7 PS (n=97, 93, 89, 95) | -13.3 scores on a scale | Standard Error 1.19 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h PS (n=101, 98, 100, 100) | -7.1 scores on a scale | Standard Error 1.48 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 3 h PS (n=101, 98, 100, 100) | -9.0 scores on a scale | Standard Error 1.42 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 9 PS (n=21, 24, 23, 22) | -14.7 scores on a scale | Standard Error 1.97 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 2 PS (n=101, 98, 100, 100) | -7.5 scores on a scale | Standard Error 1.56 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 3 PS (n=101, 97, 99, 100) | -11.3 scores on a scale | Standard Error 1.22 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 8 PS (n=61, 64, 53, 58) | -15.5 scores on a scale | Standard Error 1.25 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 4 PS (n=101, 98, 98, 101) | -12.1 scores on a scale | Standard Error 1.23 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 5 PS (n=101, 98, 97, 99) | -12.4 scores on a scale | Standard Error 1.06 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 6 PS (n=100, 98, 97, 97) | -13.6 scores on a scale | Standard Error 1.07 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Baseline (n=101, 98, 100, 100) | 18.4 scores on a scale | Standard Error 2.07 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h BS (n=101, 98, 100, 99) | 1.4 scores on a scale | Standard Error 1.54 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 1 h PS (n=100, 96, 99, 99) | -5.2 scores on a scale | Standard Error 1.68 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 6 PS (n=100, 98, 97, 97) | -12.8 scores on a scale | Standard Error 1.09 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 4 PS (n=101, 98, 98, 101) | -11.4 scores on a scale | Standard Error 1.22 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h PS (n=101, 98, 100, 100) | -6.1 scores on a scale | Standard Error 1.5 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Baseline (n=101, 98, 100, 100) | 16.4 scores on a scale | Standard Error 2.07 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 3 PS (n=101, 97, 99, 100) | -9.3 scores on a scale | Standard Error 1.23 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 2 PS (n=101, 98, 100, 100) | -5.8 scores on a scale | Standard Error 1.58 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 1 h PS (n=100, 96, 99, 99) | -3.2 scores on a scale | Standard Error 1.7 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 2 h BS (n=101, 98, 100, 99) | 4.2 scores on a scale | Standard Error 1.57 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | 3 h PS (n=101, 98, 100, 100) | -6.4 scores on a scale | Standard Error 1.43 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 5 PS (n=101, 98, 97, 99) | -12.7 scores on a scale | Standard Error 1.07 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 9 PS (n=21, 24, 23, 22) | -12.8 scores on a scale | Standard Error 1.9 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 8 PS (n=61, 64, 53, 58) | -14.7 scores on a scale | Standard Error 1.18 |
| Placebo | Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score | Day 7 PS (n=97, 93, 89, 95) | -12.4 scores on a scale | Standard Error 1.15 |
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1682ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2821ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4781ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0557ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6098ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1821ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1628ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8999ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.399ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2665ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4885ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6415ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2269ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3228ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1808ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3282ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0342ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4198ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9049ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0456ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2463ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8231ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0221ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6974ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7461ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1198ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8031ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8515ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1285ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5561ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6858ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0693ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5547ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.461ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.664ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6158ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1632ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.177ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4882ANOVA
Secondary
Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.
Time frame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Baseline (n=101, 99, 100, 100) | 0.66 scores on scales | Standard Error 0.015 |
| Pregabalin 50 mg | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Change at EOT (n=97, 98, 99, 98) | -0.01 scores on scales | Standard Error 0.016 |
| Pregabalin 150 mg | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Change at EOT (n=97, 98, 99, 98) | -0.01 scores on scales | Standard Error 0.016 |
| Pregabalin 150 mg | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Baseline (n=101, 99, 100, 100) | 0.68 scores on scales | Standard Error 0.015 |
| Pregabalin 300 mg | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Baseline (n=101, 99, 100, 100) | 0.65 scores on scales | Standard Error 0.015 |
| Pregabalin 300 mg | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Change at EOT (n=97, 98, 99, 98) | -0.01 scores on scales | Standard Error 0.015 |
| Placebo | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Baseline (n=101, 99, 100, 100) | 0.66 scores on scales | Standard Error 0.015 |
| Placebo | Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score | Change at EOT (n=97, 98, 99, 98) | -0.04 scores on scales | Standard Error 0.016 |
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7936ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5092ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4233ANOVA
Comparison: Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2033ANOVA
Comparison: Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2142ANOVA
Comparison: Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1218ANOVA
Secondary
Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS)
PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.
Time frame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS at baseline (n=101, 99, 100, 100) | 46.43 scores on a scale | Standard Error 0.914 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS change at EOT (n=99, 99, 99, 98) | -6.86 scores on a scale | Standard Error 1.013 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS at baseline (n=101, 99, 100, 100) | 54.48 scores on a scale | Standard Error 0.787 |
| Pregabalin 50 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS change at EOT (n=99, 99, 99, 98) | 2.65 scores on a scale | Standard Error 0.764 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS change at EOT (n=99, 99, 99, 98) | -7.06 scores on a scale | Standard Error 1.021 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS at baseline (n=101, 99, 100, 100) | 54.58 scores on a scale | Standard Error 0.799 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS change at EOT (n=99, 99, 99, 98) | 2.68 scores on a scale | Standard Error 0.762 |
| Pregabalin 150 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS at baseline (n=101, 99, 100, 100) | 48.14 scores on a scale | Standard Error 0.928 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS at baseline (n=101, 99, 100, 100) | 54.81 scores on a scale | Standard Error 0.787 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS change at EOT (n=99, 99, 99, 98) | -6.92 scores on a scale | Standard Error 1.011 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS change at EOT (n=99, 99, 99, 98) | 3.27 scores on a scale | Standard Error 0.75 |
| Pregabalin 300 mg | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS at baseline (n=101, 99, 100, 100) | 46.44 scores on a scale | Standard Error 0.915 |
| Placebo | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS change at EOT (n=99, 99, 99, 98) | 1.50 scores on a scale | Standard Error 0.765 |
| Placebo | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS change at EOT (n=99, 99, 99, 98) | -8.21 scores on a scale | Standard Error 1.025 |
| Placebo | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | PCSS at baseline (n=101, 99, 100, 100) | 44.89 scores on a scale | Standard Error 0.917 |
| Placebo | Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) | MCSS at baseline (n=101, 99, 100, 100) | 56.18 scores on a scale | Standard Error 0.789 |
Comparison: PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.2136ANOVA
Comparison: PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.0094ANOVA
Comparison: PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.2131ANOVA
Comparison: PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.3245ANOVA
Comparison: PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.407ANOVA
Comparison: PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.349ANOVA
Comparison: MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.1122ANOVA
Comparison: MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.138ANOVA
Comparison: MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.2023ANOVA
Comparison: MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.2639ANOVA
Comparison: MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.2524ANOVA
Comparison: MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.p-value: 0.0832ANOVA
Secondary
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.
Time frame: 3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: 3 h PS (n=99, 98, 98, 99) | -3.5 scores on a scale | Standard Error 0.84 |
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: EOT (n=97, 96, 98, 96) | -6.2 scores on a scale | Standard Error 0.64 |
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: 3 h PS (n=99, 98, 98, 99) | -1.0 scores on a scale | Standard Error 0.35 |
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: EOT (n=97, 96, 98, 96) | -2.3 scores on a scale | Standard Error 0.28 |
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: 3 h PS (n=99, 98, 99, 99) | -0.9 scores on a scale | Standard Error 0.21 |
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: EOT (n=97, 96, 99, 96) | -1.5 scores on a scale | Standard Error 0.17 |
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: 3 h PS (n=99, 98, 99, 99) | -1.5 scores on a scale | Standard Error 0.37 |
| Pregabalin 50 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: EOT (n=97, 96, 99, 96) | -2.4 scores on a scale | Standard Error 0.27 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: EOT (n=97, 96, 99, 96) | -1.7 scores on a scale | Standard Error 0.17 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: 3 h PS (n=99, 98, 99, 99) | -0.9 scores on a scale | Standard Error 0.21 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: EOT (n=97, 96, 98, 96) | -5.8 scores on a scale | Standard Error 0.64 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: EOT (n=97, 96, 99, 96) | -2.3 scores on a scale | Standard Error 0.27 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: 3 h PS (n=99, 98, 99, 99) | -1.3 scores on a scale | Standard Error 0.38 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: EOT (n=97, 96, 98, 96) | -1.8 scores on a scale | Standard Error 0.28 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: 3 h PS (n=99, 98, 98, 99) | -0.7 scores on a scale | Standard Error 0.35 |
| Pregabalin 150 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: 3 h PS (n=99, 98, 98, 99) | -2.8 scores on a scale | Standard Error 0.85 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: 3 h PS (n=99, 98, 99, 99) | -1.4 scores on a scale | Standard Error 0.37 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: 3 h PS (n=99, 98, 98, 99) | -1.1 scores on a scale | Standard Error 0.35 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: EOT (n=97, 96, 98, 96) | -2.2 scores on a scale | Standard Error 0.27 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: 3 h PS (n=99, 98, 99, 99) | -1.1 scores on a scale | Standard Error 0.21 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: EOT (n=97, 96, 99, 96) | -1.6 scores on a scale | Standard Error 0.17 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: EOT (n=97, 96, 99, 96) | -2.5 scores on a scale | Standard Error 0.26 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: 3 h PS (n=99, 98, 98, 99) | -3.6 scores on a scale | Standard Error 0.83 |
| Pregabalin 300 mg | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: EOT (n=97, 96, 98, 96) | -6.3 scores on a scale | Standard Error 0.63 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: 3 h PS (n=99, 98, 98, 99) | -0.4 scores on a scale | Standard Error 0.35 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Rumination change: EOT (n=97, 96, 98, 96) | -1.9 scores on a scale | Standard Error 0.28 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: EOT (n=97, 96, 98, 96) | -5.7 scores on a scale | Standard Error 0.64 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Total score change: 3 h PS (n=99, 98, 98, 99) | -1.5 scores on a scale | Standard Error 0.84 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: 3 h PS (n=99, 98, 99, 99) | -0.7 scores on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: EOT (n=97, 96, 99, 96) | -2.5 scores on a scale | Standard Error 0.27 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Helplessness change: 3 h PS (n=99, 98, 99, 99) | -0.5 scores on a scale | Standard Error 0.37 |
| Placebo | Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales | Magnification change: EOT (n=97, 96, 99, 96) | -1.4 scores on a scale | Standard Error 0.17 |
Comparison: Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.083ANOVA
Comparison: Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2339ANOVA
Comparison: Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0629ANOVA
Comparison: Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5721ANOVA
Comparison: Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9713ANOVA
Comparison: Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4809ANOVA
Comparison: Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1561ANOVA
Comparison: Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5267ANOVA
Comparison: Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1125ANOVA
Comparison: Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2965ANOVA
Comparison: Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7774ANOVA
Comparison: Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.399ANOVA
Comparison: Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4465ANOVA
Comparison: Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4385ANOVA
Comparison: Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2265ANOVA
Comparison: Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5985ANOVA
Comparison: Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2146ANOVA
Comparison: Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3382ANOVA
Comparison: Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.043ANOVA
Comparison: Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1128ANOVA
Comparison: Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0632ANOVA
Comparison: Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8667ANOVA
Comparison: Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6365ANOVA
Comparison: Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9275ANOVA
Secondary
Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).
Time frame: 1, 3, and 6 months (mo) post surgery (PS)
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 1 mo PS (n=20, 24, 19, 26) | 0.86 scores on a scale | Standard Deviation 0.801 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 3 mo PS (n=3, 5, 5, 3) | 0.58 scores on a scale | Standard Deviation 0.629 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 1 mo PS (n=20, 24, 19, 26) | 0.39 scores on a scale | Standard Deviation 0.63 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 3 mo PS (n=3, 5, 5, 3) | 0.14 scores on a scale | Standard Deviation 0.143 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 3 mo PS (n=3, 5, 5, 3) | 0.75 scores on a scale | Standard Deviation 0.354 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 1 mo PS (n=20, 24, 19, 26) | 0.71 scores on a scale | Standard Deviation 0.974 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 3 mo PS (n=3, 5, 5, 3) | 0.20 scores on a scale | Standard Deviation 0.163 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 1 mo PS (n=20, 24, 19, 26) | 0.81 scores on a scale | Standard Deviation 0.767 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 1 mo PS (n=20, 24, 19, 26) | 1.29 scores on a scale | Standard Deviation 1.463 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 3 mo PS (n=3, 5, 5, 3) | 1.55 scores on a scale | Standard Deviation 1.052 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 3 mo PS (n=3, 5, 5, 3) | 1.34 scores on a scale | Standard Deviation 2.14 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 1 mo PS (n=20, 24, 19, 26) | 1.43 scores on a scale | Standard Deviation 1.21 |
| Placebo | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 3 mo PS (n=3, 5, 5, 3) | 0.00 scores on a scale | Standard Deviation 0 |
| Placebo | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 3 mo PS (n=3, 5, 5, 3) | 0.42 scores on a scale | Standard Deviation 0.52 |
| Placebo | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Severity 1 mo PS (n=20, 24, 19, 26) | 0.76 scores on a scale | Standard Deviation 0.654 |
| Placebo | Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Interference 1 mo PS (n=20, 24, 19, 26) | 0.51 scores on a scale | Standard Deviation 0.895 |
Secondary
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)
NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 \[no pain\] to 10 \[worst pain imaginable\]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.
Time frame: 1, 3, and 6 months (mo) post surgery (PS)
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 3 mo PS (n=3, 5, 5, 3) | 0.22 scores on a scale | Standard Deviation 0.192 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 3 mo PS (n=3, 5, 5, 3) | 0.50 scores on a scale | Standard Deviation 0.866 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 3 mo PS (n=3, 5, 5, 3) | 0.33 scores on a scale | Standard Deviation 0.289 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 1 mo PS (n=20, 24, 19, 26) | 0.03 scores on a scale | Standard Deviation 0.025 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 1 mo PS (n=20, 24, 19, 26) | 0.82 scores on a scale | Standard Deviation 0.97 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 1 mo PS (n=20, 24, 19, 26) | 0.30 scores on a scale | Standard Deviation 0.571 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 3 mo PS (n=3, 5, 5, 3) | 1.00 scores on a scale | Standard Deviation 1.732 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 3 mo PS (n=3, 5, 5, 3) | 0.02 scores on a scale | Standard Deviation 0.032 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 1 mo PS (n=20, 24, 19, 26) | 0.10 scores on a scale | Standard Deviation 0.308 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 1 mo PS (n=20, 24, 19, 26) | 0.43 scores on a scale | Standard Deviation 0.545 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 3 mo PS (n=3, 5, 5, 3) | 0.50 scores on a scale | Standard Deviation 0.5 |
| Pregabalin 50 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 1 mo PS (n=20, 24, 19, 26) | 0.95 scores on a scale | Standard Deviation 1.708 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 3 mo PS (n=3, 5, 5, 3) | 0.02 scores on a scale | Standard Deviation 0.022 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 1 mo PS (n=20, 24, 19, 26) | 0.56 scores on a scale | Standard Deviation 1.106 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 3 mo PS (n=3, 5, 5, 3) | 0.00 scores on a scale | Standard Deviation 0 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 1 mo PS (n=20, 24, 19, 26) | 0.76 scores on a scale | Standard Deviation 0.99 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 3 mo PS (n=3, 5, 5, 3) | 1.3 scores on a scale | Standard Deviation 2.082 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 3 mo PS (n=3, 5, 5, 3) | 0.20 scores on a scale | Standard Deviation 0.274 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 1 mo PS (n=20, 24, 19, 26) | 0.03 scores on a scale | Standard Deviation 0.048 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 3 mo PS (n=3, 5, 5, 3) | 0.50 scores on a scale | Standard Deviation 0.354 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 1 mo PS (n=20, 24, 19, 26) | 0.50 scores on a scale | Standard Deviation 1.189 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 1 mo PS (n=20, 24, 19, 26) | 1.04 scores on a scale | Standard Deviation 1.574 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 3 mo PS (n=3, 5, 5, 3) | 0.20 scores on a scale | Standard Deviation 0.274 |
| Pregabalin 150 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 1 mo PS (n=20, 24, 19, 26) | 0.35 scores on a scale | Standard Deviation 0.961 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 3 mo PS (n=3, 5, 5, 3) | 0.70 scores on a scale | Standard Deviation 0.447 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 1 mo PS (n=20, 24, 19, 26) | 0.05 scores on a scale | Standard Deviation 0.038 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 3 mo PS (n=3, 5, 5, 3) | 0.05 scores on a scale | Standard Deviation 0.034 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 1 mo PS (n=20, 24, 19, 26) | 1.11 scores on a scale | Standard Deviation 1.761 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 3 mo PS (n=3, 5, 5, 3) | 0.40 scores on a scale | Standard Deviation 0.894 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 1 mo PS (n=20, 24, 19, 26) | 1.03 scores on a scale | Standard Deviation 1.307 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 3 mo PS (n=3, 5, 5, 3) | 2.30 scores on a scale | Standard Deviation 1.754 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 1 mo PS (n=20, 24, 19, 26) | 1.05 scores on a scale | Standard Deviation 1.499 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 1 mo PS (n=20, 24, 19, 26) | 1.44 scores on a scale | Standard Deviation 1.495 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 3 mo PS (n=3, 5, 5, 3) | 1.73 scores on a scale | Standard Deviation 1.234 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 1 mo PS (n=20, 24, 19, 26) | 0.32 scores on a scale | Standard Deviation 0.768 |
| Pregabalin 300 mg | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 3 mo PS (n=3, 5, 5, 3) | 0.10 scores on a scale | Standard Deviation 0.224 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 3 mo PS (n=3, 5, 5, 3) | 0.67 scores on a scale | Standard Deviation 0.764 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Pressing spont. pain 1 mo PS (n=20, 24, 19, 26) | 0.69 scores on a scale | Standard Deviation 0.939 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 1 mo PS (n=20, 24, 19, 26) | 0.04 scores on a scale | Standard Deviation 0.041 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 3 mo PS (n=3, 5, 5, 3) | 0.44 scores on a scale | Standard Deviation 0.509 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 3 mo PS (n=3, 5, 5, 3) | 1.00 scores on a scale | Standard Deviation 1.732 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Burning spont. pain 1 mo PS (n=20, 24, 19, 26) | 0.77 scores on a scale | Standard Deviation 1.557 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 3 mo PS (n=3, 5, 5, 3) | 0.50 scores on a scale | Standard Deviation 0.866 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paresth/dysesth 1 mo PS (n=20, 24, 19, 26) | 0.46 scores on a scale | Standard Deviation 0.774 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 3 mo PS (n=3, 5, 5, 3) | 1.33 scores on a scale | Standard Deviation 1.528 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal pain 1 mo PS (n=20, 24, 19, 26) | 0.71 scores on a scale | Standard Deviation 1.133 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | NPSI total score 3 mo PS (n=3, 5, 5, 3) | 0.04 scores on a scale | Standard Deviation 0.044 |
| Placebo | Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) | Evoked pain 1 mo PS (n=20, 24, 19, 26) | 1.05 scores on a scale | Standard Deviation 1.472 |
Secondary
Daily Sleep Interference Rating Scale (DSIRS) Score
DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep \[unable to sleep due to pain\]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 8 PS (n=61, 65, 54, 61) | 1.00 scores on a scale | Standard Error 0.185 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 7 PS (n=98, 96, 92, 96) | 1.04 scores on a scale | Standard Error 0.15 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 10 PS (n=11, 11, 13, 11) | 0.15 scores on a scale | Standard Error 0.349 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 5 PS (n=101, 98, 98, 100) | 1.03 scores on a scale | Standard Error 0.172 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 4 PS (n=101, 99, 99, 101) | 1.52 scores on a scale | Standard Error 0.199 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 3 PS (n=102, 98, 100, 101) | 2.13 scores on a scale | Standard Error 0.211 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 9 PS (n=21, 24, 25, 24) | 0.14 scores on a scale | Standard Error 0.24 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 6 PS (n=100, 99, 98, 99) | 0.94 scores on a scale | Standard Error 0.147 |
| Pregabalin 50 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 2 PS (n=102, 99, 101, 101) | 2.86 scores on a scale | Standard Error 0.25 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 6 PS (n=100, 99, 98, 99) | 0.98 scores on a scale | Standard Error 0.147 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 8 PS (n=61, 65, 54, 61) | 0.90 scores on a scale | Standard Error 0.18 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 7 PS (n=98, 96, 92, 96) | 0.90 scores on a scale | Standard Error 0.151 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 3 PS (n=102, 98, 100, 101) | 2.01 scores on a scale | Standard Error 0.216 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 2 PS (n=102, 99, 101, 101) | 2.61 scores on a scale | Standard Error 0.255 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 4 PS (n=101, 99, 99, 101) | 1.40 scores on a scale | Standard Error 0.201 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 10 PS (n=11, 11, 13, 11) | 1.16 scores on a scale | Standard Error 0.347 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 9 PS (n=21, 24, 25, 24) | 1.01 scores on a scale | Standard Error 0.222 |
| Pregabalin 150 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 5 PS (n=101, 98, 98, 100) | 1.22 scores on a scale | Standard Error 0.174 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 6 PS (n=100, 99, 98, 99) | 0.81 scores on a scale | Standard Error 0.147 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 2 PS (n=102, 99, 101, 101) | 2.17 scores on a scale | Standard Error 0.25 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 3 PS (n=102, 98, 100, 101) | 1.50 scores on a scale | Standard Error 0.213 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 4 PS (n=101, 99, 99, 101) | 1.27 scores on a scale | Standard Error 0.2 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 5 PS (n=101, 98, 98, 100) | 1.09 scores on a scale | Standard Error 0.173 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 7 PS (n=98, 96, 92, 96) | 0.72 scores on a scale | Standard Error 0.154 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 8 PS (n=61, 65, 54, 61) | 0.59 scores on a scale | Standard Error 0.202 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 9 PS (n=21, 24, 25, 24) | 0.40 scores on a scale | Standard Error 0.222 |
| Pregabalin 300 mg | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 10 PS (n=11, 11, 13, 11) | 0.08 scores on a scale | Standard Error 0.332 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 8 PS (n=61, 65, 54, 61) | 0.63 scores on a scale | Standard Error 0.185 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 5 PS (n=101, 98, 98, 100) | 1.44 scores on a scale | Standard Error 0.172 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 4 PS (n=101, 99, 99, 101) | 1.48 scores on a scale | Standard Error 0.198 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 10 PS (n=11, 11, 13, 11) | 0.72 scores on a scale | Standard Error 0.31 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 9 PS (n=21, 24, 25, 24) | 1.01 scores on a scale | Standard Error 0.212 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 3 PS (n=102, 98, 100, 101) | 2.11 scores on a scale | Standard Error 0.212 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 7 PS (n=98, 96, 92, 96) | 1.00 scores on a scale | Standard Error 0.15 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 6 PS (n=100, 99, 98, 99) | 1.13 scores on a scale | Standard Error 0.147 |
| Placebo | Daily Sleep Interference Rating Scale (DSIRS) Score | Day 2 PS (n=102, 99, 101, 101) | 3.18 scores on a scale | Standard Error 0.251 |
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3332ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0933ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0031ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9451ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7312ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0348ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8936ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7672ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4285ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0785ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3348ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1366ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3338ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.446ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1078ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8273ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.614ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1684ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1285ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.264ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8956ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0058ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9929ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0473ANOVA
Comparison: Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2426ANOVA
Comparison: Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3478ANOVA
Comparison: Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1694ANOVA
Secondary
Numerical Rating Scale (NRS): Current Pain at Rest
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).
Time frame: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h BS (n=102, 99, 101, 101) | 0.9 scores on scale | Standard Error 0.11 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 1 h PS (n=102, 97, 100, 100) | 3.3 scores on scale | Standard Error 0.2 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h PS (n=102, 99, 101, 101) | 3.1 scores on scale | Standard Error 0.18 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 3 h PS (n=102, 99, 101, 101) | 2.5 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 2 PS (n=101, 99, 100, 101) | 3.2 scores on scale | Standard Error 0.22 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 3 PS (n=102, 99, 100, 100) | 2.5 scores on scale | Standard Error 0.19 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 4 PS (n=101, 99, 99, 101) | 2.0 scores on scale | Standard Error 0.18 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 5 PS (n=101, 98, 98, 100) | 1.4 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 6 PS (n=100, 99, 98, 98) | 1.3 scores on scale | Standard Error 0.15 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 7 PS (n=96, 93, 90, 93) | 1.2 scores on scale | Standard Error 0.14 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 8 PS (n=60, 62, 53, 60) | 1.3 scores on scale | Standard Error 0.19 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 9 PS (n=21, 24, 25, 22) | 0.4 scores on scale | Standard Error 0.21 |
| Pregabalin 50 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 10 PS (n=11, 11, 13, 11) | 0.5 scores on scale | Standard Error 0.33 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 3 h PS (n=102, 99, 101, 101) | 2.7 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 10 PS (n=11, 11, 13, 11) | 1.0 scores on scale | Standard Error 0.33 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 8 PS (n=60, 62, 53, 60) | 1.2 scores on scale | Standard Error 0.19 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 5 PS (n=101, 98, 98, 100) | 1.8 scores on scale | Standard Error 0.17 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h PS (n=102, 99, 101, 101) | 3.2 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h BS (n=102, 99, 101, 101) | 0.7 scores on scale | Standard Error 0.12 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 7 PS (n=96, 93, 90, 93) | 1.4 scores on scale | Standard Error 0.14 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 6 PS (n=100, 99, 98, 98) | 1.4 scores on scale | Standard Error 0.15 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 3 PS (n=102, 99, 100, 100) | 2.7 scores on scale | Standard Error 0.19 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 2 PS (n=101, 99, 100, 101) | 3.3 scores on scale | Standard Error 0.23 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 1 h PS (n=102, 97, 100, 100) | 3.7 scores on scale | Standard Error 0.2 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 9 PS (n=21, 24, 25, 22) | 1.0 scores on scale | Standard Error 0.2 |
| Pregabalin 150 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 4 PS (n=101, 99, 99, 101) | 2.0 scores on scale | Standard Error 0.18 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 8 PS (n=60, 62, 53, 60) | 1.2 scores on scale | Standard Error 0.2 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 3 h PS (n=102, 99, 101, 101) | 2.6 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 2 PS (n=101, 99, 100, 101) | 3.3 scores on scale | Standard Error 0.22 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 10 PS (n=11, 11, 13, 11) | 0.9 scores on scale | Standard Error 0.31 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 3 PS (n=102, 99, 100, 100) | 2.2 scores on scale | Standard Error 0.19 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 4 PS (n=101, 99, 99, 101) | 1.9 scores on scale | Standard Error 0.18 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 9 PS (n=21, 24, 25, 22) | 0.6 scores on scale | Standard Error 0.2 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 5 PS (n=101, 98, 98, 100) | 1.8 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 6 PS (n=100, 99, 98, 98) | 1.4 scores on scale | Standard Error 0.15 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | Day 7 PS (n=96, 93, 90, 93) | 1.3 scores on scale | Standard Error 0.14 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h BS (n=102, 99, 101, 101) | 0.8 scores on scale | Standard Error 0.11 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 1 h PS (n=102, 97, 100, 100) | 2.9 scores on scale | Standard Error 0.2 |
| Pregabalin 300 mg | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h PS (n=102, 99, 101, 101) | 2.7 scores on scale | Standard Error 0.18 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 7 PS (n=96, 93, 90, 93) | 1.3 scores on scale | Standard Error 0.14 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 5 PS (n=101, 98, 98, 100) | 1.7 scores on scale | Standard Error 0.17 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | 3 h PS (n=102, 99, 101, 101) | 2.7 scores on scale | Standard Error 0.17 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h BS (n=102, 99, 101, 101) | 0.7 scores on scale | Standard Error 0.11 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 4 PS (n=101, 99, 99, 101) | 1.8 scores on scale | Standard Error 0.18 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 3 PS (n=102, 99, 100, 100) | 2.3 scores on scale | Standard Error 0.19 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | 2 h PS (n=102, 99, 101, 101) | 3.0 scores on scale | Standard Error 0.18 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | 1 h PS (n=102, 97, 100, 100) | 3.8 scores on scale | Standard Error 0.2 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 2 PS (n=101, 99, 100, 101) | 3.3 scores on scale | Standard Error 0.22 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 6 PS (n=100, 99, 98, 98) | 1.5 scores on scale | Standard Error 0.15 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 10 PS (n=11, 11, 13, 11) | 0.9 scores on scale | Standard Error 0.29 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 9 PS (n=21, 24, 25, 22) | 1.5 scores on scale | Standard Error 0.19 |
| Placebo | Numerical Rating Scale (NRS): Current Pain at Rest | Day 8 PS (n=60, 62, 53, 60) | 1.1 scores on scale | Standard Error 0.19 |
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2818ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8631ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5074ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0401ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5509ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0004ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.707ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.384ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2732ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4418ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8379ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5944ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8139ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9709ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9666ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3204ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0869ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9386ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4352ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4522ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6606ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1733ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8788ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8474ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2938ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7602ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6881ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7883ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5374ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9774ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3082ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4373ANOVA
Comparison: Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.654ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0002ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0696ANOVA
Comparison: Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0029ANOVA
Comparison: Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3695ANOVA
Comparison: Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9346ANOVA
Comparison: Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9631ANOVA
Secondary
Numeric Rating Scale (NRS): Average Pain
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).
Time frame: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | 2 h BS (n=102, 99, 101, 101) | 1.3 scores on scale | Standard Error 0.15 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | 3 h PS (n=102, 99, 101, 101) | 2.8 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | Day 4 PS (n=101, 99, 97, 100) | 1.9 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | 1 h PS (n=101, 96, 99, 99) | 2.8 scores on scale | Standard Error 0.19 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | Day 3 PS (n=102, 98, 98 101) | 2.5 scores on scale | Standard Error 0.18 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | Day 1 PS (n=101, 99, 101, 99) | 3.4 scores on scale | Standard Error 0.2 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | 2 h PS (n=101, 97, 101, 99) | 3.0 scores on scale | Standard Error 0.18 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | Day 7 PS (n=63, 66, 56, 62) | 1.6 scores on scale | Standard Error 0.19 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | Day 6 PS (n=98, 96, 91, 96) | 1.4 scores on scale | Standard Error 0.14 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | Day 2 PS (n=102, 99, 99, 100) | 2.9 scores on scale | Standard Error 0.19 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Average Pain | Day 5 PS (n=101, 99, 98, 100) | 1.6 scores on scale | Standard Error 0.15 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | Day 2 PS (n=102, 99, 99, 100) | 3.1 scores on scale | Standard Error 0.19 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | Day 5 PS (n=101, 99, 98, 100) | 1.8 scores on scale | Standard Error 0.15 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | Day 3 PS (n=102, 98, 98 101) | 2.5 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | Day 4 PS (n=101, 99, 97, 100) | 2.0 scores on scale | Standard Error 0.17 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | 2 h PS (n=101, 97, 101, 99) | 3.2 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | Day 7 PS (n=63, 66, 56, 62) | 1.5 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | 3 h PS (n=102, 99, 101, 101) | 3.2 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | Day 6 PS (n=98, 96, 91, 96) | 1.5 scores on scale | Standard Error 0.14 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | Day 1 PS (n=101, 99, 101, 99) | 3.4 scores on scale | Standard Error 0.2 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | 1 h PS (n=101, 96, 99, 99) | 3.0 scores on scale | Standard Error 0.2 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Average Pain | 2 h BS (n=102, 99, 101, 101) | 1.3 scores on scale | Standard Error 0.15 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | Day 6 PS (n=98, 96, 91, 96) | 1.7 scores on scale | Standard Error 0.14 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | 2 h BS (n=102, 99, 101, 101) | 1.3 scores on scale | Standard Error 0.15 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | 1 h PS (n=101, 96, 99, 99) | 2.5 scores on scale | Standard Error 0.19 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | 2 h PS (n=101, 97, 101, 99) | 2.8 scores on scale | Standard Error 0.18 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | 3 h PS (n=102, 99, 101, 101) | 2.9 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | Day 1 PS (n=101, 99, 101, 99) | 2.9 scores on scale | Standard Error 0.2 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | Day 2 PS (n=102, 99, 99, 100) | 2.9 scores on scale | Standard Error 0.19 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | Day 3 PS (n=102, 98, 98 101) | 2.4 scores on scale | Standard Error 0.18 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | Day 4 PS (n=101, 99, 97, 100) | 2.1 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | Day 5 PS (n=101, 99, 98, 100) | 1.7 scores on scale | Standard Error 0.15 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Average Pain | Day 7 PS (n=63, 66, 56, 62) | 1.4 scores on scale | Standard Error 0.2 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | Day 2 PS (n=102, 99, 99, 100) | 2.9 scores on scale | Standard Error 0.19 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | Day 7 PS (n=63, 66, 56, 62) | 1.3 scores on scale | Standard Error 0.19 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | Day 5 PS (n=101, 99, 98, 100) | 1.8 scores on scale | Standard Error 0.15 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | Day 1 PS (n=101, 99, 101, 99) | 3.4 scores on scale | Standard Error 0.2 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | 3 h PS (n=102, 99, 101, 101) | 3.2 scores on scale | Standard Error 0.17 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | 2 h PS (n=101, 97, 101, 99) | 3.1 scores on scale | Standard Error 0.18 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | Day 6 PS (n=98, 96, 91, 96) | 1.6 scores on scale | Standard Error 0.14 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | 1 h PS (n=101, 96, 99, 99) | 3.2 scores on scale | Standard Error 0.19 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | 2 h BS (n=102, 99, 101, 101) | 1.4 scores on scale | Standard Error 0.15 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | Day 4 PS (n=101, 99, 97, 100) | 1.9 scores on scale | Standard Error 0.17 |
| Placebo | Numeric Rating Scale (NRS): Average Pain | Day 3 PS (n=102, 98, 98 101) | 2.5 scores on scale | Standard Error 0.18 |
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6679ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7308ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6781ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.093ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3751ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0111ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6811ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7426ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1619ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1132ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9822ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1883ANOVA
Comparison: Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9391ANOVA
Comparison: Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9664ANOVA
Comparison: Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0747ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9681ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3246ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7984ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8581ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9677ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7104ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8978ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.626ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4047ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4461ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9099ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8805ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2348ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4445ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8849ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2796ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5225ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7015ANOVA
Secondary
Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)
NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).
Time frame: 1 through 48 hours post surgery (PS)
Population: MITT; data from 1 site excluded due to GCP deviations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) | 133.8 score on scale | Standard Error 7.88 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) | 141.3 score on scale | Standard Error 7.99 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) | 132.3 score on scale | Standard Error 7.78 |
| Placebo | Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) | 135.1 score on scale | Standard Error 7.86 |
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.9025ANOVA
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.5652ANOVA
Comparison: LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.792ANOVA
Secondary
Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing
NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).
Time frame: 1 hour through 48 hours post surgery
Population: MITT; 1 site excluded for GCP deviations; n=subjects with analyzable data at observation (pregabalin 50, 150, and 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Sitting (n=100, 99, 101, 101) | 146.22 scores on scale | Standard Error 8.185 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Coughing (n=101, 99, 100, 101) | 202.93 scores on scale | Standard Error 9.635 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Walking (n=97, 91, 95, 96) | 143.82 scores on scale | Standard Error 8.981 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Sitting (n=100, 99, 101, 101) | 158.90 scores on scale | Standard Error 8.261 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Coughing (n=101, 99, 100, 101) | 219.69 scores on scale | Standard Error 9.778 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Walking (n=97, 91, 95, 96) | 162.70 scores on scale | Standard Error 9.575 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Walking (n=97, 91, 95, 96) | 143.40 scores on scale | Standard Error 9.063 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Sitting (n=100, 99, 101, 101) | 148.25 scores on scale | Standard Error 8.115 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Coughing (n=101, 99, 100, 101) | 199.13 scores on scale | Standard Error 9.645 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Sitting (n=100, 99, 101, 101) | 155.57 scores on scale | Standard Error 8.125 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Coughing (n=101, 99, 100, 101) | 220.34 scores on scale | Standard Error 9.601 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing | Walking (n=97, 91, 95, 96) | 161.74 scores on scale | Standard Error 9.235 |
Comparison: Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.397ANOVA
Comparison: Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.764ANOVA
Comparison: Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.5064ANOVA
Comparison: Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.1318ANOVA
Comparison: Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.9367ANOVA
Comparison: Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.1259ANOVA
Comparison: Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.1812ANOVA
Comparison: Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.96ANOVA
Comparison: Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing.p-value: 0.105ANOVA
Secondary
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 6 PS (n=100, 99, 98, 99) | 2.6 scores on scale | Standard Error 0.23 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | EOT (n=101, 99, 100, 100) | 1.9 scores on scale | Standard Error 0.21 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 4 PS (n=101, 99, 99, 101) | 3.6 scores on scale | Standard Error 0.25 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Baseline | 2.4 scores on scale | Standard Error 0.25 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 5 PS (n=101, 99, 98, 100) | 2.8 scores on scale | Standard Error 0.24 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 1 h PS (n=95, 91, 93, 90) | 4.4 scores on scale | Standard Error 0.26 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h PS (n=96, 93, 99, 97) | 4.1 scores on scale | Standard Error 0.23 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h BS (n=102, 99, 101, 101) | 1.4 scores on scale | Standard Error 0.15 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 7 PS (n=96, 93, 91, 93) | 2.4 scores on scale | Standard Error 0.23 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 3 h PS (n=100, 99, 100, 100) | 3.8 scores on scale | Standard Error 0.22 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 2 PS (n=102, 98, 101, 100) | 4.6 scores on scale | Standard Error 0.25 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 3 PS (n=102, 98, 101, 100) | 4.3 scores on scale | Standard Error 0.24 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h BS (n=102, 99, 101, 101) | 1.5 scores on scale | Standard Error 0.15 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 3 PS (n=102, 98, 101, 100) | 4.5 scores on scale | Standard Error 0.25 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h PS (n=96, 93, 99, 97) | 4.3 scores on scale | Standard Error 0.24 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 5 PS (n=101, 99, 98, 100) | 3.1 scores on scale | Standard Error 0.24 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 6 PS (n=100, 99, 98, 99) | 2.8 scores on scale | Standard Error 0.23 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 4 PS (n=101, 99, 99, 101) | 3.6 scores on scale | Standard Error 0.25 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Baseline | 1.8 scores on scale | Standard Error 0.26 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 2 PS (n=102, 98, 101, 100) | 5.1 scores on scale | Standard Error 0.26 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 3 h PS (n=100, 99, 100, 100) | 4.1 scores on scale | Standard Error 0.22 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 1 h PS (n=95, 91, 93, 90) | 4.8 scores on scale | Standard Error 0.26 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | EOT (n=101, 99, 100, 100) | 2.0 scores on scale | Standard Error 0.21 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 7 PS (n=96, 93, 91, 93) | 2.5 scores on scale | Standard Error 0.24 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 4 PS (n=101, 99, 99, 101) | 3.6 scores on scale | Standard Error 0.25 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Baseline | 2.2 scores on scale | Standard Error 0.26 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h BS (n=102, 99, 101, 101) | 1.6 scores on scale | Standard Error 0.15 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 1 h PS (n=95, 91, 93, 90) | 3.7 scores on scale | Standard Error 0.26 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h PS (n=96, 93, 99, 97) | 3.8 scores on scale | Standard Error 0.23 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 3 h PS (n=100, 99, 100, 100) | 3.8 scores on scale | Standard Error 0.22 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 2 PS (n=102, 98, 101, 100) | 4.5 scores on scale | Standard Error 0.25 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 3 PS (n=102, 98, 101, 100) | 4.3 scores on scale | Standard Error 0.25 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 5 PS (n=101, 99, 98, 100) | 3.2 scores on scale | Standard Error 0.24 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 6 PS (n=100, 99, 98, 99) | 2.9 scores on scale | Standard Error 0.23 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 7 PS (n=96, 93, 91, 93) | 2.5 scores on scale | Standard Error 0.24 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | EOT (n=101, 99, 100, 100) | 2.3 scores on scale | Standard Error 0.21 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 2 PS (n=102, 98, 101, 100) | 5.2 scores on scale | Standard Error 0.25 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 3 h PS (n=100, 99, 100, 100) | 3.9 scores on scale | Standard Error 0.22 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Baseline | 2.1 scores on scale | Standard Error 0.26 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 6 PS (n=100, 99, 98, 99) | 3.2 scores on scale | Standard Error 0.23 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h PS (n=96, 93, 99, 97) | 4.3 scores on scale | Standard Error 0.23 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 1 h PS (n=95, 91, 93, 90) | 4.6 scores on scale | Standard Error 0.26 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | EOT (n=101, 99, 100, 100) | 2.3 scores on scale | Standard Error 0.21 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 7 PS (n=96, 93, 91, 93) | 2.7 scores on scale | Standard Error 0.23 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 4 PS (n=101, 99, 99, 101) | 3.9 scores on scale | Standard Error 0.25 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 3 PS (n=102, 98, 101, 100) | 4.5 scores on scale | Standard Error 0.24 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | 2 h BS (n=102, 99, 101, 101) | 1.8 scores on scale | Standard Error 0.15 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Coughing | Day 5 PS (n=101, 99, 98, 100) | 3.8 scores on scale | Standard Error 0.24 |
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2912ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3723ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6116ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0835ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1497ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.395ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5892ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6143ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0104ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5666ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9008ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0967ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8353ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.453ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7297ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0692ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6333ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0325ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5788ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9224ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5527ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2624ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3263ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3746ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.005ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0493ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0773ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0547ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1976ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3832ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4216ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5852ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7336ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1647ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2813ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8423ANOVA
Secondary
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 6 PS (n=100, 99, 98, 99) | 1.6 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | EOT (n=101, 99, 100, 100) | 1.0 scores on scale | Standard Error 0.15 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 4 PS (n=101, 99, 99, 101) | 2.2 scores on scale | Standard Error 0.2 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Baseline | 1.3 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 5 PS (n=101, 99, 98, 100) | 1.7 scores on scale | Standard Error 0.18 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 1 h PS (n=92, 91, 91, 91) | 3.6 scores on scale | Standard Error 0.24 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h PS (n=96, 93, 100, 96) | 3.3 scores on scale | Standard Error 0.21 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h BS (n=102, 99, 101, 101) | 0.7 scores on scale | Standard Error 0.1 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 7 PS (n=96, 93, 91, 93) | 1.5 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 3 h PS (n=100, 98, 101, 101) | 2.7 scores on scale | Standard Error 0.19 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 2 PS (n=102, 98, 101, 100) | 3.5 scores on scale | Standard Error 0.22 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 3 PS (n=102, 98, 100, 101) | 2.7 scores on scale | Standard Error 0.22 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h BS (n=102, 99, 101, 101) | 0.6 scores on scale | Standard Error 0.1 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 3 PS (n=102, 98, 100, 101) | 3.0 scores on scale | Standard Error 0.22 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h PS (n=96, 93, 100, 96) | 3.7 scores on scale | Standard Error 0.21 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 5 PS (n=101, 99, 98, 100) | 1.8 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 6 PS (n=100, 99, 98, 99) | 1.6 scores on scale | Standard Error 0.17 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 4 PS (n=101, 99, 99, 101) | 2.2 scores on scale | Standard Error 0.2 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Baseline | 1.2 scores on scale | Standard Error 0.18 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 2 PS (n=102, 98, 101, 100) | 3.6 scores on scale | Standard Error 0.23 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 3 h PS (n=100, 98, 101, 101) | 3.3 scores on scale | Standard Error 0.19 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 1 h PS (n=92, 91, 91, 91) | 4.1 scores on scale | Standard Error 0.24 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | EOT (n=101, 99, 100, 100) | 1.3 scores on scale | Standard Error 0.15 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 7 PS (n=96, 93, 91, 93) | 1.5 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 4 PS (n=101, 99, 99, 101) | 2.4 scores on scale | Standard Error 0.2 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Baseline | 1.0 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h BS (n=102, 99, 101, 101) | 0.8 scores on scale | Standard Error 0.1 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 1 h PS (n=92, 91, 91, 91) | 3.1 scores on scale | Standard Error 0.24 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h PS (n=96, 93, 100, 96) | 3.2 scores on scale | Standard Error 0.2 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 3 h PS (n=100, 98, 101, 101) | 2.9 scores on scale | Standard Error 0.18 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 2 PS (n=102, 98, 101, 100) | 3.4 scores on scale | Standard Error 0.22 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 3 PS (n=102, 98, 100, 101) | 3.0 scores on scale | Standard Error 0.22 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 5 PS (n=101, 99, 98, 100) | 1.9 scores on scale | Standard Error 0.18 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 6 PS (n=100, 99, 98, 99) | 1.8 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 7 PS (n=96, 93, 91, 93) | 1.8 scores on scale | Standard Error 0.18 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | EOT (n=101, 99, 100, 100) | 1.3 scores on scale | Standard Error 0.15 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 2 PS (n=102, 98, 101, 100) | 3.7 scores on scale | Standard Error 0.22 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 3 h PS (n=100, 98, 101, 101) | 3.1 scores on scale | Standard Error 0.19 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Baseline | 1.1 scores on scale | Standard Error 0.17 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 6 PS (n=100, 99, 98, 99) | 1.7 scores on scale | Standard Error 0.17 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h PS (n=96, 93, 100, 96) | 3.5 scores on scale | Standard Error 0.21 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 1 h PS (n=92, 91, 91, 91) | 4.1 scores on scale | Standard Error 0.24 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | EOT (n=101, 99, 100, 100) | 1.2 scores on scale | Standard Error 0.15 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 7 PS (n=96, 93, 91, 93) | 1.5 scores on scale | Standard Error 0.17 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 4 PS (n=101, 99, 99, 101) | 2.3 scores on scale | Standard Error 0.2 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 3 PS (n=102, 98, 100, 101) | 2.8 scores on scale | Standard Error 0.22 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | 2 h BS (n=102, 99, 101, 101) | 0.9 scores on scale | Standard Error 0.1 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Sitting | Day 5 PS (n=101, 99, 98, 100) | 2.0 scores on scale | Standard Error 0.18 |
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4471ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7248ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7556ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0571ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0197ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2398ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0709ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9902ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0018ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4639ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4845ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1641ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1025ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5615ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2904ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6017ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8549ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3386ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.707ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5244ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4245ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8624ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7552ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7329ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3053ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.529ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7951ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.715ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4566ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.775ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9241ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8994ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2088ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2152ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7662ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7579ANOVA
Secondary
Numeric Rating Scale (NRS): Current Pain With Movement - Walking
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 6 PS (n=100, 99, 98, 99) | 1.5 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | EOT (n=101, 99, 100, 100) | 1.1 scores on scale | Standard Error 0.16 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 4 PS (n=101, 99, 99, 101) | 2.2 scores on scale | Standard Error 0.2 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Baseline | 1.9 scores on scale | Standard Error 0.23 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 5 PS (n=101, 99, 98, 100) | 1.7 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 1 h PS (n=69, 62, 63, 60) | 3.2 scores on scale | Standard Error 0.29 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h PS (n=84, 76, 84, 80) | 3.3 scores on scale | Standard Error 0.27 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h BS (n=102, 98, 101, 101) | 1.2 scores on scale | Standard Error 0.12 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 7 PS (n=96, 93, 91, 93) | 1.3 scores on scale | Standard Error 0.17 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 3 h PS (n=96, 91, 93, 94) | 3.1 scores on scale | Standard Error 0.22 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 2 PS (n=102, 98, 101, 100) | 3.3 scores on scale | Standard Error 0.23 |
| Pregabalin 50 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 3 PS (n=102, 98, 100, 101) | 2.7 scores on scale | Standard Error 0.21 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h BS (n=102, 98, 101, 101) | 1.1 scores on scale | Standard Error 0.12 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 3 PS (n=102, 98, 100, 101) | 3.0 scores on scale | Standard Error 0.22 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h PS (n=84, 76, 84, 80) | 3.4 scores on scale | Standard Error 0.28 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 5 PS (n=101, 99, 98, 100) | 1.8 scores on scale | Standard Error 0.17 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 6 PS (n=100, 99, 98, 99) | 1.6 scores on scale | Standard Error 0.17 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 4 PS (n=101, 99, 99, 101) | 2.2 scores on scale | Standard Error 0.2 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Baseline | 1.6 scores on scale | Standard Error 0.24 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 2 PS (n=102, 98, 101, 100) | 3.8 scores on scale | Standard Error 0.23 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 3 h PS (n=96, 91, 93, 94) | 3.6 scores on scale | Standard Error 0.23 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 1 h PS (n=69, 62, 63, 60) | 3.9 scores on scale | Standard Error 0.32 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | EOT (n=101, 99, 100, 100) | 1.2 scores on scale | Standard Error 0.16 |
| Pregabalin 150 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 7 PS (n=96, 93, 91, 93) | 1.4 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 4 PS (n=101, 99, 99, 101) | 2.1 scores on scale | Standard Error 0.2 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Baseline | 1.9 scores on scale | Standard Error 0.23 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h BS (n=102, 98, 101, 101) | 1.2 scores on scale | Standard Error 0.12 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 1 h PS (n=69, 62, 63, 60) | 2.9 scores on scale | Standard Error 0.31 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h PS (n=84, 76, 84, 80) | 3.1 scores on scale | Standard Error 0.25 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 3 h PS (n=96, 91, 93, 94) | 3.0 scores on scale | Standard Error 0.22 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 2 PS (n=102, 98, 101, 100) | 3.3 scores on scale | Standard Error 0.23 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 3 PS (n=102, 98, 100, 101) | 2.8 scores on scale | Standard Error 0.21 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 5 PS (n=101, 99, 98, 100) | 1.8 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 6 PS (n=100, 99, 98, 99) | 1.7 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 7 PS (n=96, 93, 91, 93) | 1.5 scores on scale | Standard Error 0.17 |
| Pregabalin 300 mg | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | EOT (n=101, 99, 100, 100) | 1.3 scores on scale | Standard Error 0.16 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 2 PS (n=102, 98, 101, 100) | 3.9 scores on scale | Standard Error 0.23 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 3 h PS (n=96, 91, 93, 94) | 3.3 scores on scale | Standard Error 0.23 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Baseline | 2.0 scores on scale | Standard Error 0.23 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 6 PS (n=100, 99, 98, 99) | 1.6 scores on scale | Standard Error 0.17 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h PS (n=84, 76, 84, 80) | 3.6 scores on scale | Standard Error 0.27 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 1 h PS (n=69, 62, 63, 60) | 3.7 scores on scale | Standard Error 0.32 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | EOT (n=101, 99, 100, 100) | 1.2 scores on scale | Standard Error 0.16 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 7 PS (n=96, 93, 91, 93) | 1.3 scores on scale | Standard Error 0.17 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 4 PS (n=101, 99, 99, 101) | 2.2 scores on scale | Standard Error 0.2 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 3 PS (n=102, 98, 100, 101) | 2.9 scores on scale | Standard Error 0.21 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | 2 h BS (n=102, 98, 101, 101) | 1.2 scores on scale | Standard Error 0.12 |
| Placebo | Numeric Rating Scale (NRS): Current Pain With Movement - Walking | Day 5 PS (n=101, 99, 98, 100) | 1.9 scores on scale | Standard Error 0.17 |
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6896ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1934ANOVA
Comparison: Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6034ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7992ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.477ANOVA
Comparison: 2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.873ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5059ANOVA
Comparison: 1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0348ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3815ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4716ANOVA
Comparison: 2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1063ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3884ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3787ANOVA
Comparison: 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2537ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0952ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7725ANOVA
Comparison: Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.066ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3657ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7717ANOVA
Comparison: Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5849ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.958ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9884ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6743ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2689ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6907ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4798ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5609ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9834ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8339ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.873ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.6327ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3986ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.637ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9869ANOVA
Comparison: EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.755ANOVA
Secondary
Participants With Chronic Postoperative Pain
Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: In the last 24 hours, have you had pain in the area affected by your surgery?)
Time frame: 1, 3, and 6 months (mo) post surgery (PS)
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 50 mg | Participants With Chronic Postoperative Pain | 6 month PS (n=98, 97, 97, 97) | 1 participants |
| Pregabalin 50 mg | Participants With Chronic Postoperative Pain | 1 month PS (n=98, 98, 98, 99) | 20 participants |
| Pregabalin 50 mg | Participants With Chronic Postoperative Pain | 3 month PS (n=98, 97, 97, 97) | 3 participants |
| Pregabalin 150 mg | Participants With Chronic Postoperative Pain | 3 month PS (n=98, 97, 97, 97) | 5 participants |
| Pregabalin 150 mg | Participants With Chronic Postoperative Pain | 1 month PS (n=98, 98, 98, 99) | 24 participants |
| Pregabalin 150 mg | Participants With Chronic Postoperative Pain | 6 month PS (n=98, 97, 97, 97) | 1 participants |
| Pregabalin 300 mg | Participants With Chronic Postoperative Pain | 3 month PS (n=98, 97, 97, 97) | 5 participants |
| Pregabalin 300 mg | Participants With Chronic Postoperative Pain | 1 month PS (n=98, 98, 98, 99) | 19 participants |
| Pregabalin 300 mg | Participants With Chronic Postoperative Pain | 6 month PS (n=98, 97, 97, 97) | 1 participants |
| Placebo | Participants With Chronic Postoperative Pain | 1 month PS (n=98, 98, 98, 99) | 26 participants |
| Placebo | Participants With Chronic Postoperative Pain | 6 month PS (n=98, 97, 97, 97) | 0 participants |
| Placebo | Participants With Chronic Postoperative Pain | 3 month PS (n=98, 97, 97, 97) | 3 participants |
Comparison: 1 month PS.p-value: 0.2371Cochran-Mantel-Haenszel
Comparison: 1 month PS.p-value: 0.4435Cochran-Mantel-Haenszel
Comparison: 1 month PS.p-value: 0.1692Cochran-Mantel-Haenszel
Comparison: 3 month PS.p-value: 0.8169Cochran-Mantel-Haenszel
Comparison: 3 month PS.p-value: 0.5592Cochran-Mantel-Haenszel
Comparison: 3 month PS.p-value: 0.4453Cochran-Mantel-Haenszel
Comparison: 6 month PS.p-value: 0.4795Cochran-Mantel-Haenszel
Comparison: 6 month PS.p-value: 0.2733Cochran-Mantel-Haenszel
Comparison: 6 month PS.p-value: 0.3173Cochran-Mantel-Haenszel
Secondary
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).
Time frame: 3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 72 h PS (101, 98, 98, 97) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 24 h PS (n=99, 97, 100, 97) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 72 h PS (n=101, 97, 98, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue EOT (n=100, 98, 100, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 3 h PS (n=99, 98, 98, 100) | 5 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 24 h PS (n=98, 98, 99, 97) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 72 h PS (n=100, 98, 98, 98) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness EOT (n=100, 98, 100, 97) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 3 h PS (n=100, 97, 98, 99) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 24 h PS (n=99, 98, 100, 97) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 3 h PS (n=99, 98, 98, 100) | 4 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr EOT (n=100, 98, 100, 99) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 3 h PS (n=101, 97, 99, 100) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 24 h PS (n=100, 99, 101, 98) | 3 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea EOT (n=101, 98, 100, 99) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 3 h PS (n=101, 97, 99, 100) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 24 h PS (n=100, 98, 99, 98) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 72 h PS (n=101, 98, 97, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness EOT (n=101, 98, 100, 99) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 3 h PS (n=101, 98, 99, 100) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 24 h PS (n=99, 99, 100, 98) | 4 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 72 h PS (n=99, 97, 98, 98) | 4 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation EOT (n=101, 98, 99, 99) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 3 h PS (n=100, 98, 99, 100) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 24 h PS (n=100, 99, 101, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 72 h PS (n=100, 99, 99, 97) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching EOT (n=101, 98, 100, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 3 h PS (n=101, 98, 99, 99) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 24 h PS (n=100, 99, 100, 98) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 72 h PS (n=100, 99, 99, 98) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating EOT (n= 101, 98, 100, 99) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 3 h PS (n=101, 98, 99, 100) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 24 h PS (n=101, 99, 99, 98) | 1 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 72 h PS (n=100, 99, 99, 98) | 2 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion EOT (n=101, 98, 100, 99) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 3 h PS (n=101, 98, 99, 100) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 24 h PS (n=101, 99, 100, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Pregabalin 50 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting EOT (n=101, 98, 100, 99) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 24 h PS (n=100, 99, 100, 98) | 4 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 3 h PS (n=101, 98, 99, 100) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 3 h PS (n=101, 98, 99, 100) | 3 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 24 h PS (n=101, 99, 100, 98) | 2 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion EOT (n=101, 98, 100, 99) | 2 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 24 h PS (n=99, 99, 100, 98) | 4 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 72 h PS (n=100, 98, 98, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 3 h PS (n=101, 98, 99, 99) | 3 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr EOT (n=100, 98, 100, 99) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 72 h PS (n=99, 97, 98, 98) | 7 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting EOT (n=101, 98, 100, 99) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching EOT (n=101, 98, 100, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation EOT (n=101, 98, 99, 99) | 2 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 72 h PS (101, 98, 98, 97) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 72 h PS (n=100, 99, 99, 97) | 1 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 24 h PS (n=100, 99, 101, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 3 h PS (n=100, 98, 99, 100) | 1 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 24 h PS (n=98, 98, 99, 97) | 7 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 3 h PS (n=101, 98, 99, 100) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating EOT (n= 101, 98, 100, 99) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea EOT (n=101, 98, 100, 99) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 3 h PS (n=100, 97, 98, 99) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 3 h PS (n=99, 98, 98, 100) | 4 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 3 h PS (n=101, 97, 99, 100) | 1 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 3 h PS (n=101, 97, 99, 100) | 1 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue EOT (n=100, 98, 100, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 72 h PS (n=100, 99, 99, 98) | 1 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 24 h PS (n=100, 98, 99, 98) | 3 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 24 h PS (n=99, 98, 100, 97) | 1 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 72 h PS (n=101, 97, 98, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness EOT (n=100, 98, 100, 97) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 72 h PS (n=101, 98, 97, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 24 h PS (n=101, 99, 99, 98) | 1 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 24 h PS (n=99, 97, 100, 97) | 3 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 72 h PS (n=100, 99, 99, 98) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness EOT (n=101, 98, 100, 99) | 0 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 24 h PS (n=100, 99, 101, 98) | 4 participants |
| Pregabalin 150 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 3 h PS (n=99, 98, 98, 100) | 2 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating EOT (n= 101, 98, 100, 99) | 3 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 72 h PS (101, 98, 98, 97) | 1 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr EOT (n=100, 98, 100, 99) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 3 h PS (n=101, 97, 99, 100) | 1 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 24 h PS (n=100, 99, 101, 98) | 3 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 24 h PS (n=101, 99, 99, 98) | 2 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea EOT (n=101, 98, 100, 99) | 2 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 3 h PS (n=101, 97, 99, 100) | 5 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 24 h PS (n=100, 98, 99, 98) | 6 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 72 h PS (n=100, 99, 99, 98) | 3 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 72 h PS (n=101, 98, 97, 98) | 1 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness EOT (n=101, 98, 100, 99) | 1 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 3 h PS (n=101, 98, 99, 100) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 24 h PS (n=99, 99, 100, 98) | 7 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion EOT (n=101, 98, 100, 99) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 72 h PS (n=99, 97, 98, 98) | 10 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation EOT (n=101, 98, 99, 99) | 5 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 3 h PS (n=100, 98, 99, 100) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 24 h PS (n=100, 99, 101, 98) | 1 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 3 h PS (n=101, 98, 99, 100) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 72 h PS (n=100, 99, 99, 97) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching EOT (n=101, 98, 100, 98) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 3 h PS (n=101, 98, 99, 99) | 2 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 24 h PS (n=100, 99, 100, 98) | 5 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 24 h PS (n=101, 99, 100, 98) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 3 h PS (n=99, 98, 98, 100) | 2 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 24 h PS (n=99, 97, 100, 97) | 6 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 72 h PS (n=100, 99, 99, 98) | 3 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 72 h PS (n=101, 97, 98, 98) | 1 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue EOT (n=100, 98, 100, 98) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 3 h PS (n=99, 98, 98, 100) | 4 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 24 h PS (n=98, 98, 99, 97) | 8 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 3 h PS (n=101, 98, 99, 100) | 3 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 72 h PS (n=100, 98, 98, 98) | 1 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness EOT (n=100, 98, 100, 97) | 2 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting EOT (n=101, 98, 100, 99) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 3 h PS (n=100, 97, 98, 99) | 0 participants |
| Pregabalin 300 mg | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 24 h PS (n=99, 98, 100, 97) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 3 h PS (n=100, 97, 98, 99) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness EOT (n=101, 98, 100, 99) | 0 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 72 h PS (n=100, 98, 98, 98) | 3 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 3 h PS (n=99, 98, 98, 100) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 72 h PS (n=100, 99, 99, 98) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 72 h PS (n=101, 98, 97, 98) | 0 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating EOT (n= 101, 98, 100, 99) | 0 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 24 h PS (n=99, 97, 100, 97) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 3 h PS (n=101, 97, 99, 100) | 4 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 24 h PS (n=100, 98, 99, 98) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 3 h PS (n=101, 98, 99, 100) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue 72 h PS (n=101, 97, 98, 98) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 72 h PS (n=100, 99, 99, 98) | 0 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Dizziness 3 h PS (n=101, 97, 99, 100) | 6 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness EOT (n=100, 98, 100, 97) | 3 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Fatigue EOT (n=100, 98, 100, 98) | 3 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 24 h PS (n=101, 99, 100, 98) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea EOT (n=101, 98, 100, 99) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 72 h PS (101, 98, 98, 97) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 3 h PS (n=99, 98, 98, 100) | 4 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 3 h PS (n=100, 98, 99, 100) | 0 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting EOT (n=101, 98, 100, 99) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion 24 h PS (n=101, 99, 99, 98) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 24 h PS (n=100, 99, 101, 98) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation EOT (n=101, 98, 99, 99) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr EOT (n=100, 98, 100, 99) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching 72 h PS (n=100, 99, 99, 97) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 3 h PS (n=101, 98, 99, 100) | 3 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Confusion EOT (n=101, 98, 100, 99) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Drowsiness 24 h PS (n=98, 98, 99, 97) | 3 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Itching EOT (n=101, 98, 100, 98) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 72 h PS (n=99, 97, 98, 98) | 7 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 24 h PS (n=99, 99, 100, 98) | 5 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Inability to concentr 24 h PS (n=99, 98, 100, 97) | 2 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 3 h PS (n=101, 98, 99, 99) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Constipation 3 h PS (n=101, 98, 99, 100) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Retching/Vomiting 72 h PS (n=101, 99, 99, 98) | 0 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Nausea 24 h PS (n=100, 99, 101, 98) | 1 participants |
| Placebo | Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Difficulty Urinating 24 h PS (n=100, 99, 100, 98) | 3 participants |
Comparison: Fatigue at 3 h PS;p-value: 0.4024Cochran-Mantel-Haenszel
Comparison: Fatigue at 3 h PS;p-value: 0.9766Cochran-Mantel-Haenszel
Comparison: Fatigue at 3 h PS;p-value: 0.9975Cochran-Mantel-Haenszel
Comparison: Fatigue at 24 h PS;p-value: 0.9038Cochran-Mantel-Haenszel
Comparison: Fatigue at 24 h PS;p-value: 0.937Cochran-Mantel-Haenszel
Comparison: Fatigue at 24 h PS;p-value: 0.2134Cochran-Mantel-Haenszel
Comparison: Fatigue at 72 h PS;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Fatigue at 72 h PS;p-value: 0.2207Cochran-Mantel-Haenszel
Comparison: Fatigue at 72 h PS;p-value: 0.9191Cochran-Mantel-Haenszel
Comparison: Fatigue at EOT;p-value: 0.0686Cochran-Mantel-Haenszel
Comparison: Fatigue at EOT;p-value: 0.0746Cochran-Mantel-Haenszel
Comparison: Fatigue at EOT;p-value: 0.0512Cochran-Mantel-Haenszel
Comparison: Drowsiness at 3 h PS;p-value: 0.7118Cochran-Mantel-Haenszel
Comparison: Drowsiness at 3 h PS;p-value: 0.9883Cochran-Mantel-Haenszel
Comparison: Drowsiness at 3 h PS;p-value: 0.977Cochran-Mantel-Haenszel
Comparison: Drowsiness at 24 h PS;p-value: 0.5457Cochran-Mantel-Haenszel
Comparison: Drowsiness at 24 h PS;p-value: 0.2579Cochran-Mantel-Haenszel
Comparison: Drowsiness at 24 h PS;p-value: 0.1232Cochran-Mantel-Haenszel
Comparison: Drowsiness at 72 h PS;p-value: 0.288Cochran-Mantel-Haenszel
Comparison: Drowsiness at 72 h PS;p-value: 0.0894Cochran-Mantel-Haenszel
Comparison: Drowsiness at 72 h PS;p-value: 0.1979Cochran-Mantel-Haenszel
Comparison: Drowsiness at EOT;p-value: 0.0686Cochran-Mantel-Haenszel
Comparison: Drowsiness at EOT;p-value: 0.0746Cochran-Mantel-Haenszel
Comparison: Drowsiness at EOT;p-value: 0.4669Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 3 h PS;p-value: 0.5533Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 3 h PS;p-value: 0.1611Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 3 h PS;p-value: 0.1611Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 24 h PS;p-value: 0.4793Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 24 h PS;p-value: 0.3533Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 24 h PS;p-value: 0.8852Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 72 h PS;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 72 h PS;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at 72 h PS;p-value: 0.8864Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at EOT;p-value: 0.8084Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at EOT;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Inability to Concentrate at EOT;p-value: 0.2207Cochran-Mantel-Haenszel
Comparison: Nausea at 3 h PS;p-value: 0.3747Cochran-Mantel-Haenszel
Comparison: Nausea at 3 h PS;p-value: 0.145Cochran-Mantel-Haenszel
Comparison: Nausea at 3 h PS;p-value: 0.2054Cochran-Mantel-Haenszel
Comparison: Nausea at 24 h PS;p-value: 0.4106Cochran-Mantel-Haenszel
Comparison: Nausea at 24 h PS;p-value: 0.2199Cochran-Mantel-Haenszel
Comparison: Dizziness at 3 h PS;p-value: 0.1703Cochran-Mantel-Haenszel
Comparison: Nausea at 24 h PS;p-value: 0.2896Cochran-Mantel-Haenszel
Comparison: Nausea at EOT;p-value: 1Cochran-Mantel-Haenszel
Comparison: Nausea at EOT;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Nausea at EOT;p-value: 0.3943Cochran-Mantel-Haenszel
Comparison: Dizziness at 3 h PS;p-value: 0.0807Cochran-Mantel-Haenszel
Comparison: Dizziness at 3 h PS;p-value: 0.7728Cochran-Mantel-Haenszel
Comparison: Dizziness at 24 h PS;p-value: 0.477Cochran-Mantel-Haenszel
Comparison: Dizziness at 24 h PS;p-value: 0.3625Cochran-Mantel-Haenszel
Comparison: Dizziness at 24 h PS;p-value: 0.0617Cochran-Mantel-Haenszel
Comparison: Dizziness at 72 h PS;p-value: 0.3061Cochran-Mantel-Haenszel
Comparison: Dizziness at EOT;p-value: 0.2207Cochran-Mantel-Haenszel
Comparison: Dizziness at EOT;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Constipation at 3 h PS;p-value: 0.9191Cochran-Mantel-Haenszel
Comparison: Constipation at 3 h PS;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Constipation at 3 h PS;p-value: 0.2207Cochran-Mantel-Haenszel
Comparison: Constipation at 24 h PS;p-value: 0.6692Cochran-Mantel-Haenszel
Comparison: Constipation at 24 h PS;p-value: 0.7793Cochran-Mantel-Haenszel
Comparison: Constipation at 24 h PS;p-value: 0.6065Cochran-Mantel-Haenszel
Comparison: Constipation at 72 h PS;p-value: 0.357Cochran-Mantel-Haenszel
Comparison: Constipation at 72 h PS;p-value: 0.969Cochran-Mantel-Haenszel
Comparison: Constipation at 72 h PS;p-value: 0.5299Cochran-Mantel-Haenszel
Comparison: Constipation at EOT;p-value: 0.4821Cochran-Mantel-Haenszel
Comparison: Constipation at EOT;p-value: 0.8295Cochran-Mantel-Haenszel
Comparison: Constipation at EOT;p-value: 0.3304Cochran-Mantel-Haenszel
Comparison: Itching at 3 h PS;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Itching at 24 h PS;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Itching at 24 h PS;p-value: 0.2207Cochran-Mantel-Haenszel
Comparison: Itching at 24 h PS;p-value: 0.8055Cochran-Mantel-Haenszel
Comparison: Itching at 72 h PS;p-value: 0.9191Cochran-Mantel-Haenszel
Comparison: Itching at 72 h PS;p-value: 0.8488Cochran-Mantel-Haenszel
Comparison: Itching at 72 h PS;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Itching at EOT;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Itching at EOT;p-value: 0.2207Cochran-Mantel-Haenszel
Comparison: Itching at EOT;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 3 h PS;p-value: 0.3291Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 3 h PS;p-value: 0.1391Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 3 h PS;p-value: 0.6318Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 24 h PS;p-value: 0.6319Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 24 h PS;p-value: 0.8149Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 24 h PS;p-value: 0.5795Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 72 h PS;p-value: 0.175Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at 72 h PS;p-value: 0.0676Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at EOT;p-value: 0.2943Cochran-Mantel-Haenszel
Comparison: Difficulty Urinating at EOT;p-value: 0.0719Cochran-Mantel-Haenszel
Comparison: Confusion at 3 h PS;p-value: 0.9283Cochran-Mantel-Haenszel
Comparison: Confusion at 3 h PS;p-value: 0.9024Cochran-Mantel-Haenszel
Comparison: Confusion at 3 h PS;p-value: 0.7655Cochran-Mantel-Haenszel
Comparison: Confusion at 24 h PS;p-value: 1Cochran-Mantel-Haenszel
Comparison: Confusion at 24 h PS;p-value: 0.846Cochran-Mantel-Haenszel
Comparison: Confusion at 24 h PS;p-value: 0.6419Cochran-Mantel-Haenszel
Comparison: Confusion at 72 h PS;p-value: 0.9522Cochran-Mantel-Haenszel
Comparison: Confusion at 72 h PS;p-value: 0.58Cochran-Mantel-Haenszel
Comparison: Confusion at 72 h PS;p-value: 0.7675Cochran-Mantel-Haenszel
Comparison: Confusion at EOT;p-value: 0.1672Cochran-Mantel-Haenszel
Comparison: Confusion at EOT;p-value: 0.9634Cochran-Mantel-Haenszel
Comparison: Confusion at EOT;p-value: 0.1161Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at 3 h PS;p-value: 0.0754Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at 3 h PS;p-value: 0.0711Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at 3 h PS;p-value: 0.0711Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at 24 h PS;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at 24 h PS;p-value: 0.8091Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at 24 h PS;p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at EOT;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at EOT;p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Retching/Vomiting at EOT;p-value: 0.4386Cochran-Mantel-Haenszel
Secondary
Participants With Physician Contacts Post-discharge
Number of participants who answered yes to the Post-Surgery Contact question: From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?
Time frame: 24 and 72 hours (h) post surgery (PS)
Population: MITT; data from 1 site excluded due to GCP deviations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 50 mg | Participants With Physician Contacts Post-discharge | 24 h PS | 0 participants |
| Pregabalin 50 mg | Participants With Physician Contacts Post-discharge | 72 h PS | 1 participants |
| Pregabalin 150 mg | Participants With Physician Contacts Post-discharge | 72 h PS | 3 participants |
| Pregabalin 150 mg | Participants With Physician Contacts Post-discharge | 24 h PS | 2 participants |
| Pregabalin 300 mg | Participants With Physician Contacts Post-discharge | 24 h PS | 1 participants |
| Pregabalin 300 mg | Participants With Physician Contacts Post-discharge | 72 h PS | 1 participants |
| Placebo | Participants With Physician Contacts Post-discharge | 24 h PS | 0 participants |
| Placebo | Participants With Physician Contacts Post-discharge | 72 h PS | 1 participants |
Comparison: 24 h PS.p-value: 0.1927Cochran-Mantel-Haenszel
Comparison: 72 h PSp-value: 0.3865Cochran-Mantel-Haenszel
Comparison: 72 h PS.p-value: 0.9869Cochran-Mantel-Haenszel
Comparison: 72 h PS.p-value: 0.4354Cochran-Mantel-Haenszel
Comparison: 72 h PS.p-value: 0.8061Cochran-Mantel-Haenszel
Secondary
Participants With Wound Healing Complications
Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.
Time frame: Day 7 post surgery (PS) and up to 30 days PS
Population: Operated subjects within the safety population. Safety population=all randomized subjects administered at least 1 dose of study drug and for whom at least 1 post-baseline safety evaluation was obtained.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 50 mg | Participants With Wound Healing Complications | Organ/space surgical site infection | 0 participants |
| Pregabalin 50 mg | Participants With Wound Healing Complications | Superficial incisional surgical site infection | 1 participants |
| Pregabalin 50 mg | Participants With Wound Healing Complications | Non-infectious wound healing complication | 2 participants |
| Pregabalin 50 mg | Participants With Wound Healing Complications | Deep incisional surgical site infection | 0 participants |
| Pregabalin 50 mg | Participants With Wound Healing Complications | No surgical wound complication | 102 participants |
| Pregabalin 150 mg | Participants With Wound Healing Complications | Deep incisional surgical site infection | 0 participants |
| Pregabalin 150 mg | Participants With Wound Healing Complications | Organ/space surgical site infection | 0 participants |
| Pregabalin 150 mg | Participants With Wound Healing Complications | Non-infectious wound healing complication | 1 participants |
| Pregabalin 150 mg | Participants With Wound Healing Complications | Superficial incisional surgical site infection | 0 participants |
| Pregabalin 150 mg | Participants With Wound Healing Complications | No surgical wound complication | 102 participants |
| Pregabalin 300 mg | Participants With Wound Healing Complications | Deep incisional surgical site infection | 0 participants |
| Pregabalin 300 mg | Participants With Wound Healing Complications | No surgical wound complication | 99 participants |
| Pregabalin 300 mg | Participants With Wound Healing Complications | Superficial incisional surgical site infection | 1 participants |
| Pregabalin 300 mg | Participants With Wound Healing Complications | Organ/space surgical site infection | 0 participants |
| Pregabalin 300 mg | Participants With Wound Healing Complications | Non-infectious wound healing complication | 1 participants |
| Placebo | Participants With Wound Healing Complications | Organ/space surgical site infection | 0 participants |
| Placebo | Participants With Wound Healing Complications | Superficial incisional surgical site infection | 1 participants |
| Placebo | Participants With Wound Healing Complications | No surgical wound complication | 101 participants |
| Placebo | Participants With Wound Healing Complications | Deep incisional surgical site infection | 0 participants |
| Placebo | Participants With Wound Healing Complications | Non-infectious wound healing complication | 1 participants |
Secondary
Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.
Time frame: Baseline and Days 1 and 7 post surgery (PS)
Population: MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.
Secondary
Subject Global Evaluation of Study Medication (GESM)
GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.
Time frame: 24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Poor (n=99, 99, 100, 100) | 9 participants |
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Fair (n=100, 96, 101, 99) | 29 participants |
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Excellent (n=99, 99, 100, 100) | 31 participants |
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Good (n=100, 96, 101, 99) | 45 participants |
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Good (n=99, 99, 100, 100) | 45 participants |
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Excellent (n=100, 96, 101, 99) | 16 participants |
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Poor (n=100, 96, 101, 99) | 10 participants |
| Pregabalin 50 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Fair (n=99, 99, 100, 100) | 14 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Poor (n=100, 96, 101, 99) | 8 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Good (n=99, 99, 100, 100) | 37 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Excellent (n=99, 99, 100, 100) | 33 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Poor (n=99, 99, 100, 100) | 10 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Good (n=100, 96, 101, 99) | 46 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Fair (n=100, 96, 101, 99) | 28 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Excellent (n=100, 96, 101, 99) | 14 participants |
| Pregabalin 150 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Fair (n=99, 99, 100, 100) | 19 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Good (n=100, 96, 101, 99) | 42 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Fair (n=100, 96, 101, 99) | 25 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Poor (n=99, 99, 100, 100) | 6 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Excellent (n=99, 99, 100, 100) | 50 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Poor (n=100, 96, 101, 99) | 7 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Good (n=99, 99, 100, 100) | 30 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | EOT: Fair (n=99, 99, 100, 100) | 14 participants |
| Pregabalin 300 mg | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Excellent (n=100, 96, 101, 99) | 27 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | EOT: Excellent (n=99, 99, 100, 100) | 31 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Fair (n=100, 96, 101, 99) | 32 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Poor (n=100, 96, 101, 99) | 15 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Good (n=100, 96, 101, 99) | 40 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | 24 h PS: Excellent (n=100, 96, 101, 99) | 12 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | EOT: Poor (n=99, 99, 100, 100) | 18 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | EOT: Fair (n=99, 99, 100, 100) | 19 participants |
| Placebo | Subject Global Evaluation of Study Medication (GESM) | EOT: Good (n=99, 99, 100, 100) | 32 participants |
Comparison: 24 h PS.p-value: 0.1723Cochran-Mantel-Haenszel
Comparison: 24 h PSp-value: 0.0639Cochran-Mantel-Haenszel
Comparison: 24 h PS.p-value: 0.0021Cochran-Mantel-Haenszel
Comparison: EOT.p-value: 0.1127Cochran-Mantel-Haenszel
Comparison: EOT.p-value: 0.0703Cochran-Mantel-Haenszel
Comparison: EOT.p-value: 0.0012Cochran-Mantel-Haenszel
Secondary
Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)
Time frame: Day 1
Population: MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.
Secondary
Time From End of Surgery to First Rescue Medication
Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.
Time frame: Day 1 through Day 7 post surgery
Population: MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.
Secondary
Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)
PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.
Time frame: Day 1
Population: MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.
Secondary
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 \[none\] to 10 \[10 CMEs\]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 \[none\] to 9 \[9 CMEs\]).
Time frame: 3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 3 h PS (n=98, 97, 98, 98) | 0.2 scores on a scale | Standard Error 0.07 |
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 24 h PS (n=97, 97, 98, 97) | 0.2 scores on a scale | Standard Error 0.07 |
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 72 h PS (n=98, 96, 96, 96) | 0.1 scores on a scale | Standard Error 0.05 |
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME EOT (n=100, 98, 99, 97) | 0.0 scores on a scale | Standard Error 0.04 |
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 3 h PS (n=98, 97, 98, 98) | 0.2 scores on a scale | Standard Error 0.07 |
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 24 h PS (n=93, 95, 96, 94) | 0.3 scores on a scale | Standard Error 0.1 |
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 72 h PS (n=91, 92, 93, 92) | 0.3 scores on a scale | Standard Error 0.11 |
| Pregabalin 50 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME EOT (n=90, 92, 93, 89) | 0.3 scores on a scale | Standard Error 0.11 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 24 h PS (n=93, 95, 96, 94) | 0.4 scores on a scale | Standard Error 0.1 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 3 h PS (n=98, 97, 98, 98) | 0.2 scores on a scale | Standard Error 0.07 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 24 h PS (n=97, 97, 98, 97) | 0.3 scores on a scale | Standard Error 0.07 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME EOT (n=90, 92, 93, 89) | 0.5 scores on a scale | Standard Error 0.11 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 72 h PS (n=91, 92, 93, 92) | 0.5 scores on a scale | Standard Error 0.11 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME EOT (n=100, 98, 99, 97) | 0.1 scores on a scale | Standard Error 0.04 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 72 h PS (n=98, 96, 96, 96) | 0.1 scores on a scale | Standard Error 0.05 |
| Pregabalin 150 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 3 h PS (n=98, 97, 98, 98) | 0.2 scores on a scale | Standard Error 0.07 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 72 h PS (n=91, 92, 93, 92) | 0.5 scores on a scale | Standard Error 0.11 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 72 h PS (n=98, 96, 96, 96) | 0.2 scores on a scale | Standard Error 0.05 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME EOT (n=100, 98, 99, 97) | 0.1 scores on a scale | Standard Error 0.04 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 3 h PS (n=98, 97, 98, 98) | 0.1 scores on a scale | Standard Error 0.07 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 24 h PS (n=93, 95, 96, 94) | 0.4 scores on a scale | Standard Error 0.09 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME EOT (n=90, 92, 93, 89) | 0.6 scores on a scale | Standard Error 0.11 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 3 h PS (n=98, 97, 98, 98) | 0.1 scores on a scale | Standard Error 0.07 |
| Pregabalin 300 mg | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 24 h PS (n=97, 97, 98, 97) | 0.4 scores on a scale | Standard Error 0.07 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 72 h PS (n=98, 96, 96, 96) | 0.1 scores on a scale | Standard Error 0.05 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME EOT (n=100, 98, 99, 97) | 0.1 scores on a scale | Standard Error 0.04 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 24 h PS (n=97, 97, 98, 97) | 0.2 scores on a scale | Standard Error 0.07 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | Total CME 3 h PS (n=98, 97, 98, 98) | 0.2 scores on a scale | Standard Error 0.07 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 3 h PS (n=98, 97, 98, 98) | 0.2 scores on a scale | Standard Error 0.07 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME EOT (n=90, 92, 93, 89) | 0.6 scores on a scale | Standard Error 0.11 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 72 h PS (n=91, 92, 93, 92) | 0.5 scores on a scale | Standard Error 0.11 |
| Placebo | Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) | CT Distinct CME 24 h PS (n=93, 95, 96, 94) | 0.4 scores on a scale | Standard Error 0.1 |
Comparison: Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4273ANOVA
Comparison: Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4466ANOVA
Comparison: Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3785ANOVA
Comparison: Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5272ANOVA
Comparison: Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4257ANOVA
Comparison: Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1428ANOVA
Comparison: Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2316ANOVA
Comparison: Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3468ANOVA
Comparison: Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5367ANOVA
Comparison: Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0549ANOVA
Comparison: Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1351ANOVA
Comparison: Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9599ANOVA
Comparison: CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4273ANOVA
Comparison: CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.4466ANOVA
Comparison: CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3785ANOVA
Comparison: CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2869ANOVA
Comparison: CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9905ANOVA
Comparison: CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.9381ANOVA
Comparison: CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2158ANOVA
Comparison: CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.7887ANOVA
Comparison: CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.925ANOVA
Comparison: CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1472ANOVA
Comparison: CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.5383ANOVA
Comparison: CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.8869ANOVA
Secondary
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery
Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.
Time frame: 24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS
Population: MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). During surgery data not analyzed as planned.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin 50 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 24 h PS (n=102, 99, 101, 101) | 10.29 mg | Standard Error 2.275 |
| Pregabalin 50 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 6 PS (n=101, 99, 99, 100) | 15.99 mg | Standard Error 4.072 |
| Pregabalin 50 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 5 PS (n=102, 99, 101, 101) | 16.09 mg | Standard Error 3.786 |
| Pregabalin 50 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 48 h PS (n=102, 99, 101, 101) | 13.15 mg | Standard Error 2.763 |
| Pregabalin 50 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 7 PS (n=99, 99, 97, 100) | 15.88 mg | Standard Error 4.291 |
| Pregabalin 50 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 72 h PS (n=102, 99, 101, 101) | 14.59 mg | Standard Error 3.088 |
| Pregabalin 50 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 4 PS (n=102, 99, 101, 101) | 15.35 mg | Standard Error 3.474 |
| Pregabalin 150 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 6 PS (n=101, 99, 99, 100) | 21.57 mg | Standard Error 4.139 |
| Pregabalin 150 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 4 PS (n=102, 99, 101, 101) | 18.65 mg | Standard Error 3.542 |
| Pregabalin 150 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 72 h PS (n=102, 99, 101, 101) | 16.99 mg | Standard Error 3.148 |
| Pregabalin 150 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 5 PS (n=102, 99, 101, 101) | 20.46 mg | Standard Error 3.86 |
| Pregabalin 150 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 7 PS (n=99, 99, 97, 100) | 22.23 mg | Standard Error 4.322 |
| Pregabalin 150 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 48 h PS (n=102, 99, 101, 101) | 14.10 mg | Standard Error 2.817 |
| Pregabalin 150 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 24 h PS (n=102, 99, 101, 101) | 9.44 mg | Standard Error 2.32 |
| Pregabalin 300 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 4 PS (n=102, 99, 101, 101) | 14.18 mg | Standard Error 3.479 |
| Pregabalin 300 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 24 h PS (n=102, 99, 101, 101) | 6.58 mg | Standard Error 2.279 |
| Pregabalin 300 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 48 h PS (n=102, 99, 101, 101) | 9.73 mg | Standard Error 2.768 |
| Pregabalin 300 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 72 h PS (n=102, 99, 101, 101) | 12.34 mg | Standard Error 3.092 |
| Pregabalin 300 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 5 PS (n=102, 99, 101, 101) | 14.64 mg | Standard Error 3.792 |
| Pregabalin 300 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 6 PS (n=101, 99, 99, 100) | 15.81 mg | Standard Error 4.105 |
| Pregabalin 300 mg | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 7 PS (n=99, 99, 97, 100) | 16.16 mg | Standard Error 4.334 |
| Placebo | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 72 h PS (n=102, 99, 101, 101) | 22.20 mg | Standard Error 3.097 |
| Placebo | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 7 PS (n=99, 99, 97, 100) | 28.15 mg | Standard Error 4.265 |
| Placebo | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 6 PS (n=101, 99, 99, 100) | 26.90 mg | Standard Error 4.085 |
| Placebo | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 48 h PS (n=102, 99, 101, 101) | 19.79 mg | Standard Error 2.772 |
| Placebo | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | 24 h PS (n=102, 99, 101, 101) | 16.03 mg | Standard Error 2.283 |
| Placebo | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 5 PS (n=102, 99, 101, 101) | 25.57 mg | Standard Error 3.798 |
| Placebo | Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery | Day 4 PS (n=102, 99, 101, 101) | 23.97 mg | Standard Error 3.485 |
Comparison: 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.063ANOVA
Comparison: 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0347ANOVA
Comparison: 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0024ANOVA
Comparison: 48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0767ANOVA
Comparison: 48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.1327ANOVA
Comparison: 48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0078ANOVA
Comparison: 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0694ANOVA
Comparison: 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2173ANOVA
Comparison: 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0193ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0673ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.2629ANOVA
Comparison: Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0388ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0651ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3242ANOVA
Comparison: Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0345ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0487ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3384ANOVA
Comparison: Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0467ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0347ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.3086ANOVA
Comparison: Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.p-value: 0.0406ANOVA