Osteoarthritis, Postoperative Pain
Conditions
Keywords
opioid
Brief summary
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
Interventions
DRUGpregabalin
150 milligram (mg)/ day (double blind)
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
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block). * Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care. * The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3
Exclusion criteria
* Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure. * Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease. * Subjects with fibromyalgia and or other chronic pain syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) | 48 hours after surgery | The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), subjects were asked to rate their pain by marking an X in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioids Used Post Discharge | Week 2, Week 4, Week 6/Early Termination (ET) | The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid. |
| Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | 24 hours, 48 hours, 72 hours | Total dose for in-hospital visits was the total dose for the day. |
| Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Week 2, Week 4, Week 6/ET | Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups | Week 2, Week 4, Week 6/ET | Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group | Week 2, Week 4, Week 6/ET | Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4 | Week 4 | Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4 | Week 4 | Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET | Week 6/ET | Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET | Week 6/ET | Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET | The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent). |
| The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET | The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe). |
| The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET | The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother). |
| Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET | Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge. |
| The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET | The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse). |
| Total Clinically Meaningful Event (CME) Score | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET | CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9. |
| Pain Interference Index Score as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes. |
| Pain Interference With Relations With People as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Pain Interference With General Activity as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes. |
| Pain Interference With Mood as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Pain Interference With Walking Ability as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Pain Interference With Normal Work as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Pain Interference With Sleep as Measured by the m-BPI-sf | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET | Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge. |
| Current Pain During the Hospital Stay Assessed by the Pain NRS | 4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay | Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question How much pain do you have right now? Scores range from 0 (no pain) to 10 (most possible pain). |
| Pain-Related Sleep Interference Post Surgery | 24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET | The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge. |
| Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery | VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety. |
| Timed Up-and-Go (TUG) | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET | TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again. |
| Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET | The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer. |
| ROM Assessment of the Passive Flexion of the Surgical Knee | 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET | The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer. |
| Time From End of Surgery to Meet Hospital Discharge Criteria | time from end of surgery up to 192 hours post surgery | The analysis was performed by Kaplan-Meier method with log-rank test. |
| Time From End of Surgery to Actual Discharge | time from end of surgery up to 192 hours post surgery | The analysis was performed by Kaplan-Meier method with log-rank test. |
| Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Discharge, Week 2, Week 4, Week 6/ET | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Satisfaction With Medication Characteristics Measured by the PTSS | Discharge, Week 2, Week 4, Week 6/ET | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Satisfaction With Medication Efficacy Measured by the PTSS | Discharge, Week 2, Week 4, Week 6/ET | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours | Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia \[PCA\] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative. |
| Overall Pain Relief Measured by the PTSS | Discharge, Week 2, Week 4, and Week 6/ET | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Week 2, Week 4, and Week 6/ET | The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject's overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent). |
| Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 3, Month 6 (phone call) | The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a no. Any positive score (1-10) of VRS was consider as yes. |
| Neuropathic Pain Symptom Inventory (NPSI) | Month 3, Month 6 (phone call) | NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain. |
| Overall Satisfaction Measured by the PTSS | Discharge, Week 2, Week 4, and Week 6/ET | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin (150 mg) Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | 98 |
| Pregabalin (300 mg) Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | 96 |
| Placebo Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. | 98 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 17 | 13 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 |
| Overall Study | Other | 4 | 9 | 6 |
| Overall Study | Randomized But Not Treated | 5 | 4 | 6 |
| Overall Study | Withdrawal by Subject | 5 | 5 | 7 |
Baseline characteristics
| Characteristic | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo | Total |
|---|---|---|---|---|
| Age, Customized 18 to 44 years | 1 participants | 2 participants | 4 participants | 7 participants |
| Age, Customized 45 to 64 years | 52 participants | 44 participants | 49 participants | 145 participants |
| Age, Customized > = 65 years | 45 participants | 50 participants | 45 participants | 140 participants |
| Sex: Female, Male Female | 60 Participants | 61 Participants | 54 Participants | 175 Participants |
| Sex: Female, Male Male | 38 Participants | 35 Participants | 44 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 76 / 98 | 76 / 96 | 81 / 98 |
| serious Total, serious adverse events | 11 / 98 | 11 / 96 | 5 / 98 |
Outcome results
Primary
Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), subjects were asked to rate their pain by marking an X in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block.
Time frame: 48 hours after surgery
Population: Modified Intent-to-Treat (MITT) Population=all ITT subjects who took 12 and 2 hours pre-surgery study medications, had no surgical or anesthetic complications during total knee replacement surgery and had at least 1 post surgery primary efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin (150 mg) | Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) | 7.041 scores on a scale | Standard Error 0.267 |
| Pregabalin (300 mg) | Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) | 6.740 scores on a scale | Standard Error 0.264 |
| Placebo | Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) | 7.079 scores on a scale | Standard Error 0.279 |
p-value: 0.918595% CI: [-0.766, 0.691]ANOVA
p-value: 0.361995% CI: [-1.07, 0.392]ANOVA
Secondary
Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)
Total dose for in-hospital visits was the total dose for the day.
Time frame: 24 hours, 48 hours, 72 hours
Population: MITT. There were not enough subjects with data to calculate least squares mean values at 24 and 48 hours for Acetylalicyclic Acid and 72 hours for Ketorolac.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Acetylsalicylic Acid, 72 hours (n=3, 1, 1) | 235.175 mg | Standard Error 61.531 |
| Pregabalin (150 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Ketorolac, 24 hours, (n=1, 4, 3) | 32.961 mg | Standard Error 57.23 |
| Pregabalin (150 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Ketorolac, 48 hours, (n=2, 8, 4) | 20.553 mg | Standard Error 7.971 |
| Pregabalin (150 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 24 hours (n=14, 20, 16) | 1311.246 mg | Standard Error 359.886 |
| Pregabalin (150 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 48 hours (n=22, 25, 17) | 1357.030 mg | Standard Error 371.095 |
| Pregabalin (150 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 72 hours (n=12, 13, 16) | 446.050 mg | Standard Error 445.588 |
| Pregabalin (300 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 72 hours (n=12, 13, 16) | 877.916 mg | Standard Error 403.657 |
| Pregabalin (300 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Acetylsalicylic Acid, 72 hours (n=3, 1, 1) | 1442.025 mg | Standard Error 117.823 |
| Pregabalin (300 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 24 hours (n=14, 20, 16) | 1363.086 mg | Standard Error 283.808 |
| Pregabalin (300 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 48 hours (n=22, 25, 17) | 1368.880 mg | Standard Error 339.509 |
| Pregabalin (300 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Ketorolac, 24 hours, (n=1, 4, 3) | 53.432 mg | Standard Error 28.615 |
| Pregabalin (300 mg) | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Ketorolac, 48 hours, (n=2, 8, 4) | 21.863 mg | Standard Error 3.862 |
| Placebo | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Ketorolac, 24 hours, (n=1, 4, 3) | 27.189 mg | Standard Error 31.346 |
| Placebo | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Ketorolac, 48 hours, (n=2, 8, 4) | 23.473 mg | Standard Error 5.52 |
| Placebo | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 72 hours (n=12, 13, 16) | 1128.355 mg | Standard Error 347.457 |
| Placebo | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 24 hours (n=14, 20, 16) | 1380.481 mg | Standard Error 309.224 |
| Placebo | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Acetylsalicylic Acid, 72 hours (n=3, 1, 1) | 1425.825 mg | Standard Error 117.823 |
| Placebo | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) | Paracetamol, 48 hours (n=22, 25, 17) | 1263.337 mg | Standard Error 443.695 |
Comparison: Paracetamol, 48 hoursp-value: 0.818595% CI: [-813.584, 1024.67]ANOVA
Comparison: Acetylsalicylic Acid, 72 hoursp-value: 0.065695% CI: [-2754.304, 373.004]ANOVA
Comparison: Acetylsalicylic Acid, 72 hoursp-value: 0.927795% CI: [-1789.352, 1821.752]ANOVA
Comparison: Ketorolac, 24 hoursp-value: 0.93595% CI: [-263.972, 275.515]ANOVA
Comparison: Ketorolac, 24 hoursp-value: 0.613995% CI: [-164.494, 216.98]ANOVA
Comparison: Ketorolac, 48 hoursp-value: 0.77695% CI: [-25.451, 19.611]ANOVA
Comparison: Ketorolac, 48 hoursp-value: 0.81995% CI: [-17.066, 13.846]ANOVA
Comparison: Paracetamol, 24 hoursp-value: 0.860395% CI: [-861.171, 722.7]ANOVA
Comparison: Paracetamol, 24 hoursp-value: 0.964295% CI: [-796.945, 762.155]ANOVA
Comparison: Paracetamol, 48 hoursp-value: 0.847695% CI: [-880.865, 1068.251]ANOVA
Comparison: Paracetamol, 72 hoursp-value: 0.179295% CI: [-1696.759, 332.15]ANOVA
Comparison: Paracetamol, 72 hoursp-value: 0.621695% CI: [-1278.347, 777.469]ANOVA
Secondary
Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4
Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
Time frame: Week 4
Population: MITT
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Pregabalin (150 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4 | 650.000 mg | Full Range 0 |
| Pregabalin (300 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4 | 22.100 mg | — |
p-value: <0.000195% CI: [302.9, 302.9]ANOVA
Secondary
Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET
Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
Time frame: Week 6/ET
Population: MITT
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin (150 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET | 513.163 mg | Standard Error 200.647 |
Secondary
Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET
Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
Time frame: Week 6/ET
Population: MITT
Secondary
Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4
Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
Time frame: Week 4
Secondary
Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
Time frame: Week 2, Week 4, Week 6/ET
Population: MITT.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 4 (n=5, 12, 6) | 792.434 mg | Standard Error 412.26 |
| Pregabalin (150 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 6/ET (n=6, 14, 5) | 1128.952 mg | Standard Error 290.993 |
| Pregabalin (150 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Acetylsalicylic Acid, Week 2 (n=6, 1, 2) | 498.613 mg | Standard Error 130.446 |
| Pregabalin (150 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 2 (n=7, 13, 7) | 603.496 mg | Standard Error 232.179 |
| Pregabalin (300 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 4 (n=5, 12, 6) | 779.226 mg | Standard Error 260.034 |
| Pregabalin (300 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 2 (n=7, 13, 7) | 665.574 mg | Standard Error 164.777 |
| Pregabalin (300 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 6/ET (n=6, 14, 5) | 1098.840 mg | Standard Error 223.948 |
| Pregabalin (300 mg) | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Acetylsalicylic Acid, Week 2 (n=6, 1, 2) | 797.463 mg | Standard Error 361.189 |
| Placebo | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 6/ET (n=6, 14, 5) | 1385.873 mg | Standard Error 334.859 |
| Placebo | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Acetylsalicylic Acid, Week 2 (n=6, 1, 2) | 992.613 mg | Standard Error 291.687 |
| Placebo | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 2 (n=7, 13, 7) | 630.787 mg | Standard Error 247.693 |
| Placebo | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] | Paracetamol, Week 4 (n=5, 12, 6) | 593.498 mg | Standard Error 375.124 |
Comparison: Acetylsalicylic Acid, Week 2.p-value: 0.199695% CI: [-1452.72, 464.72]ANOVA
Comparison: Acetylsalicylic Acid, Week 2.p-value: 0.633595% CI: [-1369.338, 979.038]ANOVA
Comparison: Paracetamol, Week 2p-value: 0.92995% CI: [-657.992, 603.41]ANOVA
Comparison: Paracetamol, Week 2p-value: 0.893795% CI: [-501.241, 570.815]ANOVA
Comparison: Paracetamol, Week 4p-value: 0.691295% CI: [-847.93, 1245.804]ANOVA
Comparison: Paracetamol, Week 4p-value: 0.602495% CI: [-558.248, 929.704]ANOVA
Comparison: Paracetamol, Week 6/ETp-value: 0.537295% CI: [-1120.551, 606.709]ANOVA
Comparison: Paracetamol, Week 6/ETp-value: 0.394895% CI: [-982.843, 408.778]ANOVA
Secondary
Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
Time frame: Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at Week 2 and Week 4 for Ibuprofen to calculate least squares mean values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin (150 mg) | Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups | 862.350 mg | Standard Error 584.827 |
| Pregabalin (300 mg) | Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups | 983.850 mg | Standard Error 1119.858 |
p-value: 0.934195% CI: [-14983.36, 14740.362]ANOVA
Secondary
Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
Time frame: Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at Week 2 for Ibuprofen to calculate least squares mean values.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group | Week 4 | — |
| Unknown | Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group | Week 6 | — |
Secondary
Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery
VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety.
Time frame: Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery
Population: MITT. There were not enough subjects with data at 6 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | Day 1 (n=83, 79, 78) | 6.133 scores on a scale | Standard Error 2.395 |
| Pregabalin (150 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 1 hour (n=68, 67, 59) | 6.974 scores on a scale | Standard Error 2.787 |
| Pregabalin (150 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 2 hours (n=75, 76, 63) | 3.792 scores on a scale | Standard Error 2.86 |
| Pregabalin (150 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 3 hours (n=52, 58, 63) | 7.477 scores on a scale | Standard Error 3.466 |
| Pregabalin (150 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 4 hours (n=19, 17, 20) | 8.218 scores on a scale | Standard Error 5.803 |
| Pregabalin (150 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 5 hours (n=3, 4, 8) | 71.190 scores on a scale | Standard Error 16.886 |
| Pregabalin (300 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 5 hours (n=3, 4, 8) | 29.819 scores on a scale | Standard Error 7.644 |
| Pregabalin (300 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | Day 1 (n=83, 79, 78) | 7.103 scores on a scale | Standard Error 2.45 |
| Pregabalin (300 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 3 hours (n=52, 58, 63) | 7.588 scores on a scale | Standard Error 3.188 |
| Pregabalin (300 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 4 hours (n=19, 17, 20) | 0.109 scores on a scale | Standard Error 6.15 |
| Pregabalin (300 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 1 hour (n=68, 67, 59) | 3.272 scores on a scale | Standard Error 2.805 |
| Pregabalin (300 mg) | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 2 hours (n=75, 76, 63) | 6.818 scores on a scale | Standard Error 2.844 |
| Placebo | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 1 hour (n=68, 67, 59) | 6.085 scores on a scale | Standard Error 3.013 |
| Placebo | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 2 hours (n=75, 76, 63) | 6.454 scores on a scale | Standard Error 3.126 |
| Placebo | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 5 hours (n=3, 4, 8) | -15.145 scores on a scale | Standard Error 6.572 |
| Placebo | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 3 hours (n=52, 58, 63) | 7.313 scores on a scale | Standard Error 3.108 |
| Placebo | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | Day 1 (n=83, 79, 78) | 6.992 scores on a scale | Standard Error 2.523 |
| Placebo | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery | 4 hours (n=19, 17, 20) | 10.133 scores on a scale | Standard Error 5.527 |
Comparison: Day 1p-value: 0.795895% CI: [-7.391, 5.673]ANOVA
Comparison: Day 1p-value: 0.973395% CI: [-6.436, 6.659]ANOVA
Comparison: 1 hourp-value: 0.82295% CI: [-6.898, 8.675]ANOVA
Comparison: 1 hourp-value: 0.473695% CI: [-10.542, 4.917]ANOVA
Comparison: 2 hoursp-value: 0.511395% CI: [-10.639, 5.316]ANOVA
Comparison: 2 hoursp-value: 0.926695% CI: [-7.425, 8.154]ANOVA
Comparison: 3 hoursp-value: 0.969995% CI: [-8.423, 8.751]ANOVA
Comparison: 3 hoursp-value: 0.948295% CI: [-8.085, 8.635]ANOVA
Comparison: 4 hoursp-value: 0.796995% CI: [-16.842, 13.012]ANOVA
Comparison: 4 hoursp-value: 0.199195% CI: [-25.533, 5.487]ANOVA
Comparison: 5 hoursp-value: 0.032195% CI: [13.976, 158.693]ANOVA
Comparison: 5 hoursp-value: 0.035395% CI: [5.837, 84.091]ANOVA
Secondary
Cumulative Total Amount of Opioids Used During the Entire Hospital Stay
Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia \[PCA\] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative.
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours
Population: MITT. There were not enough subjects with data at 168, 192, and 216 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 24 hours (n=85, 86, 84) | 151.790 mg of oral morphine equivalent | Standard Error 14.21 |
| Pregabalin (150 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 48 hours (n=82, 81, 83) | 86.402 mg of oral morphine equivalent | Standard Error 12.057 |
| Pregabalin (150 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 72 hours (n=60, 60, 60) | 55.654 mg of oral morphine equivalent | Standard Error 9.175 |
| Pregabalin (150 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 96 hours (n=32, 39, 35) | 31.976 mg of oral morphine equivalent | Standard Error 7.928 |
| Pregabalin (150 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 120 hours (n=12, 6, 13) | 27.520 mg of oral morphine equivalent | Standard Error 13.146 |
| Pregabalin (150 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 144 hours (n=5, 1, 5) | 33.956 mg of oral morphine equivalent | Standard Error 12.019 |
| Pregabalin (300 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 144 hours (n=5, 1, 5) | -64.544 mg of oral morphine equivalent | Standard Error 28.633 |
| Pregabalin (300 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 24 hours (n=85, 86, 84) | 152.306 mg of oral morphine equivalent | Standard Error 14.313 |
| Pregabalin (300 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 96 hours (n=32, 39, 35) | 24.758 mg of oral morphine equivalent | Standard Error 7.861 |
| Pregabalin (300 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 120 hours (n=12, 6, 13) | 14.235 mg of oral morphine equivalent | Standard Error 17.684 |
| Pregabalin (300 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 48 hours (n=82, 81, 83) | 93.846 mg of oral morphine equivalent | Standard Error 12.292 |
| Pregabalin (300 mg) | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 72 hours (n=60, 60, 60) | 48.713 mg of oral morphine equivalent | Standard Error 9.42 |
| Placebo | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 48 hours (n=82, 81, 83) | 122.830 mg of oral morphine equivalent | Standard Error 12.304 |
| Placebo | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 72 hours (n=60, 60, 60) | 52.895 mg of oral morphine equivalent | Standard Error 9.851 |
| Placebo | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 144 hours (n=5, 1, 5) | 73.956 mg of oral morphine equivalent | Standard Error 16.72 |
| Placebo | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 96 hours (n=32, 39, 35) | 35.332 mg of oral morphine equivalent | Standard Error 8.354 |
| Placebo | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 24 hours (n=85, 86, 84) | 167.854 mg of oral morphine equivalent | Standard Error 14.573 |
| Placebo | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay | 120 hours (n=12, 6, 13) | 27.559 mg of oral morphine equivalent | Standard Error 13.306 |
Comparison: 24 hoursp-value: 0.409195% CI: [-54.332, 22.203]ANOVA
Comparison: 24 hoursp-value: 0.423495% CI: [-53.74, 22.645]ANOVA
Comparison: 48 hoursp-value: 0.028495% CI: [-68.972, -3.884]ANOVA
Comparison: 48 hoursp-value: 0.081695% CI: [-61.632, 3.663]ANOVA
Comparison: 72 hoursp-value: 0.814795% CI: [-20.446, 25.964]ANOVA
Comparison: 72 hoursp-value: 0.718795% CI: [-27.064, 18.7]ANOVA
Comparison: 96 hoursp-value: 0.741695% CI: [-23.516, 16.804]ANOVA
Comparison: 96 hoursp-value: 0.257795% CI: [-29.017, 7.869]ANOVA
Comparison: 120 hoursp-value: 0.998295% CI: [-36.431, 36.352]ANOVA
Comparison: 120 hoursp-value: 0.555295% CI: [-59.756, 33.107]ANOVA
Comparison: 144 hoursp-value: 0.203295% CI: [-118.463, 38.463]ANOVA
Comparison: 144 hoursp-value: 0.034895% CI: [-258.354, -18.646]ANOVA
Secondary
Current Pain During the Hospital Stay Assessed by the Pain NRS
Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question How much pain do you have right now? Scores range from 0 (no pain) to 10 (most possible pain).
Time frame: 4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay
Population: MITT. There were not enough subjects with data at 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 80 hours (n=19, 24, 24) | 5.312 scores on a scale | Standard Error 0.678 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 40 hours (n=62, 55, 55) | 3.720 scores on a scale | Standard Error 0.401 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 12 hours (n=66, 68, 64) | 4.779 scores on a scale | Standard Error 0.385 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 72 hours (n=51, 45, 45) | 3.971 scores on a scale | Standard Error 0.344 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 48 hours (n=78, 72, 70) | 4.095 scores on a scale | Standard Error 0.276 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 8 hours (n=82, 79, 75) | 5.083 scores on a scale | Standard Error 0.305 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 64 hours (n=46, 37, 45) | 4.220 scores on a scale | Standard Error 0.458 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 56 hours (n=62, 56, 57) | 4.015 scores on a scale | Standard Error 0.329 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 88 hours (n=16, 13, 20) | 4.265 scores on a scale | Standard Error 0.714 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 24 hours (n=87, 88, 82) | 4.500 scores on a scale | Standard Error 0.265 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 104 hours (n=7, 3, 7) | 3.501 scores on a scale | Standard Error 0.908 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 4 hours (n=84, 84, 78) | 4.940 scores on a scale | Standard Error 0.345 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 32 hours (n=79, 78, 69) | 4.450 scores on a scale | Standard Error 0.293 |
| Pregabalin (150 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 96 hours (n=16, 14, 20) | 3.525 scores on a scale | Standard Error 0.729 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 80 hours (n=19, 24, 24) | 2.403 scores on a scale | Standard Error 0.624 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 4 hours (n=84, 84, 78) | 3.554 scores on a scale | Standard Error 0.344 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 8 hours (n=82, 79, 75) | 4.529 scores on a scale | Standard Error 0.312 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 12 hours (n=66, 68, 64) | 4.068 scores on a scale | Standard Error 0.375 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 24 hours (n=87, 88, 82) | 4.545 scores on a scale | Standard Error 0.262 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 32 hours (n=79, 78, 69) | 4.507 scores on a scale | Standard Error 0.296 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 40 hours (n=62, 55, 55) | 3.821 scores on a scale | Standard Error 0.412 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 48 hours (n=78, 72, 70) | 4.069 scores on a scale | Standard Error 0.284 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 56 hours (n=62, 56, 57) | 3.358 scores on a scale | Standard Error 0.345 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 64 hours (n=46, 37, 45) | 3.492 scores on a scale | Standard Error 0.48 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 72 hours (n=51, 45, 45) | 3.271 scores on a scale | Standard Error 0.379 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 88 hours (n=16, 13, 20) | 2.767 scores on a scale | Standard Error 0.803 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 96 hours (n=16, 14, 20) | 2.532 scores on a scale | Standard Error 0.773 |
| Pregabalin (300 mg) | Current Pain During the Hospital Stay Assessed by the Pain NRS | 104 hours (n=7, 3, 7) | 2.680 scores on a scale | Standard Error 1.382 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 96 hours (n=16, 14, 20) | 2.658 scores on a scale | Standard Error 0.737 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 72 hours (n=51, 45, 45) | 3.826 scores on a scale | Standard Error 0.385 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 32 hours (n=79, 78, 69) | 4.345 scores on a scale | Standard Error 0.315 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 24 hours (n=87, 88, 82) | 4.836 scores on a scale | Standard Error 0.277 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 80 hours (n=19, 24, 24) | 4.285 scores on a scale | Standard Error 0.691 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 12 hours (n=66, 68, 64) | 4.784 scores on a scale | Standard Error 0.376 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 4 hours (n=84, 84, 78) | 4.363 scores on a scale | Standard Error 0.361 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 88 hours (n=16, 13, 20) | 3.914 scores on a scale | Standard Error 0.73 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 8 hours (n=82, 79, 75) | 5.119 scores on a scale | Standard Error 0.323 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 56 hours (n=62, 56, 57) | 3.760 scores on a scale | Standard Error 0.343 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 48 hours (n=78, 72, 70) | 3.785 scores on a scale | Standard Error 0.295 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 104 hours (n=7, 3, 7) | 1.829 scores on a scale | Standard Error 0.972 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 64 hours (n=46, 37, 45) | 4.578 scores on a scale | Standard Error 0.423 |
| Placebo | Current Pain During the Hospital Stay Assessed by the Pain NRS | 40 hours (n=62, 55, 55) | 3.902 scores on a scale | Standard Error 0.408 |
Comparison: 4 hoursp-value: 0.221195% CI: [-0.35, 1.506]ANOVA
Comparison: 4 hoursp-value: 0.091695% CI: [-1.75, 0.132]ANOVA
Comparison: 8 hoursp-value: 0.931295% CI: [-0.863, 0.791]ANOVA
Comparison: 8 hoursp-value: 0.165895% CI: [-1.428, 0.247]ANOVA
Comparison: 12 hoursp-value: 0.992195% CI: [-0.958, 0.948]ANOVA
Comparison: 12 hoursp-value: 0.136795% CI: [-1.66, 0.229]ANOVA
Comparison: 24 hoursp-value: 0.356195% CI: [-1.053, 0.38]ANOVA
Comparison: 24 hoursp-value: 0.42695% CI: [-1.012, 0.429]ANOVA
Comparison: 32 hoursp-value: 0.797595% CI: [-0.703, 0.914]ANOVA
Comparison: 32 hoursp-value: 0.694795% CI: [-0.65, 0.974]ANOVA
Comparison: 40 hoursp-value: 0.695495% CI: [-1.101, 0.736]ANOVA
Comparison: 40 hoursp-value: 0.866595% CI: [-1.032, 0.87]ANOVA
Comparison: 48 hoursp-value: 0.421695% CI: [-0.45, 1.072]ANOVA
Comparison: 48 hoursp-value: 0.467395% CI: [-0.487, 1.056]ANOVA
Comparison: 56 hoursp-value: 0.562495% CI: [-0.614, 1.125]ANOVA
Comparison: 56 hoursp-value: 0.370595% CI: [-1.286, 0.482]ANOVA
Comparison: 64 hoursp-value: 0.453995% CI: [-1.302, 0.586]ANOVA
Comparison: 64 hoursp-value: 0.037395% CI: [-2.107, -0.065]ANOVA
Comparison: 72 hoursp-value: 0.7695% CI: [-0.796, 1.087]ANOVA
Comparison: 72 hoursp-value: 0.250695% CI: [-1.507, 0.397]ANOVA
Comparison: 80 hoursp-value: 0.256795% CI: [-0.77, 2.823]ANOVA
Comparison: 80 hoursp-value: 0.016795% CI: [-3.408, -0.356]ANOVA
Comparison: 88 hoursp-value: 0.695395% CI: [-1.456, 2.159]ANOVA
Comparison: 88 hoursp-value: 0.20895% CI: [-2.962, 0.668]ANOVA
Comparison: 96 hoursp-value: 0.380595% CI: [-1.116, 2.849]ANOVA
Comparison: 96 hoursp-value: 0.8995% CI: [-1.965, 1.713]ANOVA
Comparison: 104 hoursp-value: 0.182195% CI: [-1.103, 4.448]ANOVA
Comparison: 104 hoursp-value: 0.650595% CI: [-3.693, 5.395]ANOVA
Secondary
Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS
Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.
Time frame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 72 hours (n=56, 51, 55) | 4.281 scores on a scale | Standard Error 0.28 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 6/ET (n=60, 54, 59) | 2.374 scores on a scale | Standard Error 0.215 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 120 hours (n=5, 3, 9) | 4.211 scores on a scale | Standard Error 1.002 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 96 hours (n=20, 21, 26) | 4.842 scores on a scale | Standard Error 0.514 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 12 hours (n=29, 28, 28) | 5.712 scores on a scale | Standard Error 0.55 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 4 (n=76, 65, 67) | 2.956 scores on a scale | Standard Error 0.18 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 48 hours (n=78, 82, 75) | 4.518 scores on a scale | Standard Error 0.238 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 24 hours (n=81, 79, 74) | 4.961 scores on a scale | Standard Error 0.255 |
| Pregabalin (150 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 2 (n=79, 72, 71) | 3.691 scores on a scale | Standard Error 0.186 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 96 hours (n=20, 21, 26) | 3.126 scores on a scale | Standard Error 0.503 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 12 hours (n=29, 28, 28) | 4.845 scores on a scale | Standard Error 0.593 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 24 hours (n=81, 79, 74) | 4.614 scores on a scale | Standard Error 0.257 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 48 hours (n=78, 82, 75) | 4.309 scores on a scale | Standard Error 0.236 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 72 hours (n=56, 51, 55) | 3.740 scores on a scale | Standard Error 0.298 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 120 hours (n=5, 3, 9) | 2.940 scores on a scale | Standard Error 1.566 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 2 (n=79, 72, 71) | 3.974 scores on a scale | Standard Error 0.198 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 4 (n=76, 65, 67) | 2.845 scores on a scale | Standard Error 0.197 |
| Pregabalin (300 mg) | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 6/ET (n=60, 54, 59) | 2.385 scores on a scale | Standard Error 0.225 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 48 hours (n=78, 82, 75) | 4.515 scores on a scale | Standard Error 0.249 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 12 hours (n=29, 28, 28) | 6.748 scores on a scale | Standard Error 0.6 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 2 (n=79, 72, 71) | 3.987 scores on a scale | Standard Error 0.206 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 24 hours (n=81, 79, 74) | 4.918 scores on a scale | Standard Error 0.266 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 6/ET (n=60, 54, 59) | 2.389 scores on a scale | Standard Error 0.234 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 96 hours (n=20, 21, 26) | 4.741 scores on a scale | Standard Error 0.488 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 72 hours (n=56, 51, 55) | 4.186 scores on a scale | Standard Error 0.29 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | Week 4 (n=76, 65, 67) | 3.163 scores on a scale | Standard Error 0.203 |
| Placebo | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS | 120 hours (n=5, 3, 9) | 4.287 scores on a scale | Standard Error 0.759 |
Comparison: 12 hoursp-value: 0.148695% CI: [-2.452, 0.379]ANOVA
Comparison: 12 hoursp-value: 0.008995% CI: [-3.311, -0.494]ANOVA
Comparison: 24 hoursp-value: 0.899595% CI: [-0.635, 0.722]ANOVA
Comparison: 24 hoursp-value: 0.391895% CI: [-1, 0.394]ANOVA
Comparison: 48 hoursp-value: 0.994295% CI: [-0.648, 0.652]ANOVA
Comparison: 48 hoursp-value: 0.535295% CI: [-0.859, 0.448]ANOVA
Comparison: 72 hoursp-value: 0.805595% CI: [-0.662, 0.85]ANOVA
Comparison: 72 hoursp-value: 0.25695% CI: [-1.22, 0.327]ANOVA
Comparison: 96 hoursp-value: 0.874495% CI: [-1.184, 1.387]ANOVA
Comparison: 96 hoursp-value: 0.011595% CI: [-2.851, -0.378]ANOVA
Comparison: 120 hoursp-value: 0.949795% CI: [-3.047, 2.893]ANOVA
Comparison: 120 hoursp-value: 0.528895% CI: [-6.467, 3.773]ANOVA
Comparison: Week 2p-value: 0.259595% CI: [-0.813, 0.22]ANOVA
Comparison: Week 2p-value: 0.960595% CI: [-0.546, 0.519]ANOVA
Comparison: Week 4p-value: 0.410795% CI: [-0.702, 0.288]ANOVA
Comparison: Week 4p-value: 0.227195% CI: [-0.836, 0.2]ANOVA
Comparison: Week 6/ETp-value: 0.955295% CI: [-0.535, 0.506]ANOVA
Comparison: Week 6/ETp-value: 0.989995% CI: [-0.533, 0.526]ANOVA
Secondary
Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)
Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.
Time frame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 72 hours (n=56, 52, 55) | 6.322 scores on a scale | Standard Error 0.333 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 6/ET (n=61, 55, 59) | 3.455 scores on a scale | Standard Error 0.267 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 120 hours (n=5, 3, 9) | 5.915 scores on a scale | Standard Error 0.819 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 96 hours (n=20, 21, 26) | 6.703 scores on a scale | Standard Error 0.624 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 12 hours (n=29, 28, 28) | 7.217 scores on a scale | Standard Error 0.597 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 4 (n=76, 65, 67) | 4.134 scores on a scale | Standard Error 0.22 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 48 hours (n=78, 82, 75) | 7.041 scores on a scale | Standard Error 0.267 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 24 hours (n=82, 79, 74) | 7.477 scores on a scale | Standard Error 0.298 |
| Pregabalin (150 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 2 (n=79, 72, 72) | 5.255 scores on a scale | Standard Error 0.209 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 96 hours (n=20, 21, 26) | 4.711 scores on a scale | Standard Error 0.618 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 12 hours (n=29, 28, 28) | 7.002 scores on a scale | Standard Error 0.649 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 24 hours (n=82, 79, 74) | 7.290 scores on a scale | Standard Error 0.301 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 48 hours (n=78, 82, 75) | 6.740 scores on a scale | Standard Error 0.264 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 72 hours (n=56, 52, 55) | 5.977 scores on a scale | Standard Error 0.35 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 120 hours (n=5, 3, 9) | 4.346 scores on a scale | Standard Error 1.446 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 2 (n=79, 72, 72) | 5.592 scores on a scale | Standard Error 0.223 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 4 (n=76, 65, 67) | 4.043 scores on a scale | Standard Error 0.241 |
| Pregabalin (300 mg) | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 6/ET (n=61, 55, 59) | 3.425 scores on a scale | Standard Error 0.276 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 48 hours (n=78, 82, 75) | 7.079 scores on a scale | Standard Error 0.279 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 12 hours (n=29, 28, 28) | 8.770 scores on a scale | Standard Error 0.635 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 2 (n=79, 72, 72) | 5.396 scores on a scale | Standard Error 0.229 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 24 hours (n=82, 79, 74) | 7.201 scores on a scale | Standard Error 0.311 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 6/ET (n=61, 55, 59) | 3.350 scores on a scale | Standard Error 0.292 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 96 hours (n=20, 21, 26) | 6.556 scores on a scale | Standard Error 0.598 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 72 hours (n=56, 52, 55) | 5.964 scores on a scale | Standard Error 0.343 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | Week 4 (n=76, 65, 67) | 4.280 scores on a scale | Standard Error 0.247 |
| Placebo | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) | 120 hours (n=5, 3, 9) | 7.056 scores on a scale | Standard Error 0.663 |
Comparison: 12 hoursp-value: 0.047695% CI: [-3.089, -0.017]ANOVA
Comparison: 12 hoursp-value: 0.023795% CI: [-3.293, -0.243]ANOVA
Comparison: 24 hoursp-value: 0.492595% CI: [-0.516, 1.069]ANOVA
Comparison: 24 hoursp-value: 0.829995% CI: [-0.727, 0.905]ANOVA
Comparison: 48 hoursp-value: 0.918595% CI: [-0.766, 0.691]ANOVA
Comparison: 48 hoursp-value: 0.361995% CI: [-1.07, 0.392]ANOVA
Comparison: 72 hoursp-value: 0.430995% CI: [-0.538, 1.254]ANOVA
Comparison: 72 hoursp-value: 0.977895% CI: [-0.895, 0.921]ANOVA
Comparison: 96 hoursp-value: 0.850395% CI: [-1.411, 1.706]ANOVA
Comparison: 96 hoursp-value: 0.018395% CI: [-3.364, -0.326]ANOVA
Comparison: 120 hoursp-value: 0.28695% CI: [-3.598, 1.316]ANOVA
Comparison: 120 hoursp-value: 0.20495% CI: [-7.479, 2.06]ANOVA
Comparison: Week 2p-value: 0.633295% CI: [-0.722, 0.44]ANOVA
Comparison: Week 2p-value: 0.518395% CI: [-0.402, 0.794]ANOVA
Comparison: Week 4p-value: 0.634195% CI: [-0.75, 0.458]ANOVA
Comparison: Week 4p-value: 0.460795% CI: [-0.868, 0.395]ANOVA
Comparison: Week 6/ETp-value: 0.749995% CI: [-0.541, 0.75]ANOVA
Comparison: Week 6/ETp-value: 0.823195% CI: [-0.584, 0.733]ANOVA
Secondary
Neuropathic Pain Symptom Inventory (NPSI)
NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.
Time frame: Month 3, Month 6 (phone call)
Population: MITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Burning Spontaneous Pain, Month 3, (n=23, 24, 29) | 1.348 scores on a scale | Standard Deviation 2.479 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Burning Spontaneous Pain, Month 6, (n=22, 15, 15) | 1.091 scores on a scale | Standard Deviation 2.114 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Pressing Spontaneous Pain, Month 3, (n=23, 24, 29) | 1.457 scores on a scale | Standard Deviation 2.083 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Pressing Spontaneous Pain, Month 6, (n=22, 15, 15) | 1.409 scores on a scale | Standard Deviation 2.158 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal Pain, Month 3, (n=23, 24, 29) | 0.804 scores on a scale | Standard Deviation 1.042 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal Pain, Month 6, (n=22, 15, 15) | 1.205 scores on a scale | Standard Deviation 2.711 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Evoked Pain, Month 3, (n=23, 24, 29) | 1.174 scores on a scale | Standard Deviation 1.7 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Evoked Pain, Month 6, (n=22, 15, 15) | 0.636 scores on a scale | Standard Deviation 0.937 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paresthesia/Dysesthesia, Month 3, (n=23, 24, 29) | 0.848 scores on a scale | Standard Deviation 1.473 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paresthesia/Dysesthesia, Month 6, (n=22, 15, 15) | 0.773 scores on a scale | Standard Deviation 1.674 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Total Score, Month 3, (n=23, 24, 29) | 0.058 scores on a scale | Standard Deviation 0.061 |
| Pregabalin (150 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Total Score, Month 6, (n=22, 15, 15) | 0.051 scores on a scale | Standard Deviation 0.074 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Total Score, Month 6, (n=22, 15, 15) | 0.061 scores on a scale | Standard Deviation 0.078 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Burning Spontaneous Pain, Month 3, (n=23, 24, 29) | 0.792 scores on a scale | Standard Deviation 2.085 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Evoked Pain, Month 3, (n=23, 24, 29) | 1.319 scores on a scale | Standard Deviation 2.004 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paresthesia/Dysesthesia, Month 3, (n=23, 24, 29) | 0.604 scores on a scale | Standard Deviation 1.406 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Burning Spontaneous Pain, Month 6, (n=22, 15, 15) | 1.400 scores on a scale | Standard Deviation 2.324 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal Pain, Month 6, (n=22, 15, 15) | 1.133 scores on a scale | Standard Deviation 2.175 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Total Score, Month 3, (n=23, 24, 29) | 0.055 scores on a scale | Standard Deviation 0.075 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Pressing Spontaneous Pain, Month 3, (n=23, 24, 29) | 0.958 scores on a scale | Standard Deviation 1.574 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Evoked Pain, Month 6, (n=22, 15, 15) | 1.667 scores on a scale | Standard Deviation 2.402 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal Pain, Month 3, (n=23, 24, 29) | 1.688 scores on a scale | Standard Deviation 2.417 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Pressing Spontaneous Pain, Month 6, (n=22, 15, 15) | 1.333 scores on a scale | Standard Deviation 1.655 |
| Pregabalin (300 mg) | Neuropathic Pain Symptom Inventory (NPSI) | Paresthesia/Dysesthesia, Month 6, (n=22, 15, 15) | 0.500 scores on a scale | Standard Deviation 1.086 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Pressing Spontaneous Pain, Month 6, (n=22, 15, 15) | 0.633 scores on a scale | Standard Deviation 1.445 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal Pain, Month 3, (n=23, 24, 29) | 1.086 scores on a scale | Standard Deviation 1.909 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Paresthesia/Dysesthesia, Month 6, (n=22, 15, 15) | 0.033 scores on a scale | Standard Deviation 0.129 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Paroxysmal Pain, Month 6, (n=22, 15, 15) | 0.533 scores on a scale | Standard Deviation 1.246 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Evoked Pain, Month 3, (n=23, 24, 29) | 0.931 scores on a scale | Standard Deviation 1.344 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Evoked Pain, Month 6, (n=22, 15, 15) | 0.711 scores on a scale | Standard Deviation 1.298 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Total Score, Month 3, (n=23, 24, 29) | 0.045 scores on a scale | Standard Deviation 0.059 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Burning Spontaneous Pain, Month 3, (n=23, 24, 29) | 0.828 scores on a scale | Standard Deviation 1.947 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Burning Spontaneous Pain, Month 6, (n=22, 15, 15) | 0.667 scores on a scale | Standard Deviation 1.113 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Paresthesia/Dysesthesia, Month 3, (n=23, 24, 29) | 0.690 scores on a scale | Standard Deviation 1.16 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Pressing Spontaneous Pain, Month 3, (n=23, 24, 29) | 0.948 scores on a scale | Standard Deviation 1.496 |
| Placebo | Neuropathic Pain Symptom Inventory (NPSI) | Total Score, Month 6, (n=22, 15, 15) | 0.027 scores on a scale | Standard Deviation 0.036 |
Secondary
Number of Subjects With Global Evaluation of Study Medication Scores
The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject's overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent).
Time frame: Discharge, Week 2, Week 4, and Week 6/ET
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Excellent (n=22, 20, 18) | 6 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Good (n=85, 84, 78) | 31 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Fair (n=85, 84, 78) | 14 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Poor (n=85, 84, 78) | 9 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Excellent (n=85, 84, 78) | 31 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Good (n=22, 20, 18) | 11 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Fair (n=22, 20, 18) | 3 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Poor (n=22, 20, 18) | 2 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Excellent (n=30, 27, 19) | 13 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Good (n=30, 27, 19) | 11 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Fair (n=30, 27, 19) | 4 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Poor (n=30, 27, 19) | 2 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Excellent (n=32, 31, 40) | 3 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Good (n=32, 31, 40) | 17 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Fair (n=32, 31, 40) | 6 participants |
| Pregabalin (150 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Poor (n=32, 31, 40) | 6 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Good (n=22, 20, 18) | 4 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Fair (n=22, 20, 18) | 4 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Poor (n=22, 20, 18) | 2 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Good (n=32, 31, 40) | 9 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Excellent (n=30, 27, 19) | 9 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Good (n=30, 27, 19) | 12 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Poor (n=32, 31, 40) | 10 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Fair (n=30, 27, 19) | 3 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Excellent (n=85, 84, 78) | 27 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Fair (n=32, 31, 40) | 5 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Good (n=85, 84, 78) | 46 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Poor (n=30, 27, 19) | 3 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Fair (n=85, 84, 78) | 6 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Poor (n=85, 84, 78) | 5 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Excellent (n=22, 20, 18) | 10 participants |
| Pregabalin (300 mg) | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Excellent (n=32, 31, 40) | 7 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Fair (n=30, 27, 19) | 3 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Good (n=22, 20, 18) | 9 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Excellent (n=32, 31, 40) | 5 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Fair (n=85, 84, 78) | 12 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Fair (n=22, 20, 18) | 1 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Poor (n=32, 31, 40) | 9 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Excellent (n=85, 84, 78) | 19 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Poor (n=22, 20, 18) | 3 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Poor (n=30, 27, 19) | 1 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 2, Excellent (n=22, 20, 18) | 5 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Excellent (n=30, 27, 19) | 7 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Good (n=32, 31, 40) | 19 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Good (n=85, 84, 78) | 39 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 4, Good (n=30, 27, 19) | 8 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Discharge, Poor (n=85, 84, 78) | 8 participants |
| Placebo | Number of Subjects With Global Evaluation of Study Medication Scores | Week 6/ET, Fair (n=32, 31, 40) | 7 participants |
Comparison: Dischargep-value: 0.2473Cochran-Mantel-Haenszel
Comparison: Dischargep-value: 0.0239Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.6118Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.673Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.5954Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.7784Cochran-Mantel-Haenszel
Comparison: Week 6/ETp-value: 0.7293Cochran-Mantel-Haenszel
Comparison: Week 6/ETp-value: 0.5202Cochran-Mantel-Haenszel
Secondary
Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)
The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a no. Any positive score (1-10) of VRS was consider as yes.
Time frame: Month 3, Month 6 (phone call)
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin (150 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 6, Yes (n=64, 62, 61) | 19 participants |
| Pregabalin (150 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 6, No (n=64, 62, 61) | 45 participants |
| Pregabalin (150 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 3, Yes (n=65, 59, 61) | 22 participants |
| Pregabalin (150 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 3, No (n=65, 59, 61) | 43 participants |
| Pregabalin (300 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 6, Yes (n=64, 62, 61) | 15 participants |
| Pregabalin (300 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 3, No (n=65, 59, 61) | 37 participants |
| Pregabalin (300 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 6, No (n=64, 62, 61) | 47 participants |
| Pregabalin (300 mg) | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 3, Yes (n=65, 59, 61) | 22 participants |
| Placebo | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 6, No (n=64, 62, 61) | 47 participants |
| Placebo | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 3, Yes (n=65, 59, 61) | 27 participants |
| Placebo | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 3, No (n=65, 59, 61) | 34 participants |
| Placebo | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) | Month 6, Yes (n=64, 62, 61) | 14 participants |
Comparison: Month 3p-value: 0.1509Cochran-Mantel-Haenszel
Comparison: Month 3p-value: 0.3822Cochran-Mantel-Haenszel
Comparison: Month 6p-value: 0.2825Cochran-Mantel-Haenszel
Comparison: Month 6p-value: 0.7733Cochran-Mantel-Haenszel
Secondary
Opioids Used Post Discharge
The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid.
Time frame: Week 2, Week 4, Week 6/Early Termination (ET)
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Opioids Used Post Discharge | Week 4 (n=33, 33, 30) | 37.130 mg of oral morphine equivalent | Standard Error 4.975 |
| Pregabalin (150 mg) | Opioids Used Post Discharge | Week 2 (n=41, 40, 36) | 30.255 mg of oral morphine equivalent | Standard Error 3.515 |
| Pregabalin (150 mg) | Opioids Used Post Discharge | Week 6/ET (n=24, 28, 22) | 38.686 mg of oral morphine equivalent | Standard Error 6.261 |
| Pregabalin (300 mg) | Opioids Used Post Discharge | Week 4 (n=33, 33, 30) | 37.507 mg of oral morphine equivalent | Standard Error 4.911 |
| Pregabalin (300 mg) | Opioids Used Post Discharge | Week 2 (n=41, 40, 36) | 27.692 mg of oral morphine equivalent | Standard Error 3.534 |
| Pregabalin (300 mg) | Opioids Used Post Discharge | Week 6/ET (n=24, 28, 22) | 35.945 mg of oral morphine equivalent | Standard Error 5.888 |
| Placebo | Opioids Used Post Discharge | Week 2 (n=41, 40, 36) | 26.119 mg of oral morphine equivalent | Standard Error 3.789 |
| Placebo | Opioids Used Post Discharge | Week 6/ET (n=24, 28, 22) | 35.036 mg of oral morphine equivalent | Standard Error 6.401 |
| Placebo | Opioids Used Post Discharge | Week 4 (n=33, 33, 30) | 34.271 mg of oral morphine equivalent | Standard Error 5.274 |
Comparison: Week 2p-value: 0.360295% CI: [-4.79, 13.062]ANOVA
Comparison: Week 2p-value: 0.735295% CI: [-7.626, 10.771]ANOVA
Comparison: Week 4p-value: 0.643595% CI: [-9.392, 15.111]ANOVA
Comparison: Week 4p-value: 0.612395% CI: [-9.422, 15.895]ANOVA
Comparison: Week 6/ETp-value: 0.635695% CI: [-11.683, 18.984]ANOVA
Comparison: Week 6/ETp-value: 0.90795% CI: [-14.593, 16.411]ANOVA
Secondary
Overall Pain Relief Measured by the PTSS
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Discharge, Week 2, Week 4, and Week 6/ET
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Overall Pain Relief Measured by the PTSS | Discharge (n=12, 17, 15) | 2.260 scores on a scale | Standard Error 0.258 |
| Pregabalin (150 mg) | Overall Pain Relief Measured by the PTSS | Week 2 (n=6, 4, 4) | 2.333 scores on a scale | Standard Error 0.827 |
| Pregabalin (150 mg) | Overall Pain Relief Measured by the PTSS | Week 4 (n=4, 3, 4) | 1.418 scores on a scale | Standard Error 0.713 |
| Pregabalin (150 mg) | Overall Pain Relief Measured by the PTSS | Week 6/ET (n=2, 5, 6) | 2.067 scores on a scale | Standard Error 1.403 |
| Pregabalin (300 mg) | Overall Pain Relief Measured by the PTSS | Week 6/ET (n=2, 5, 6) | 4.233 scores on a scale | Standard Error 0.817 |
| Pregabalin (300 mg) | Overall Pain Relief Measured by the PTSS | Discharge (n=12, 17, 15) | 1.696 scores on a scale | Standard Error 0.211 |
| Pregabalin (300 mg) | Overall Pain Relief Measured by the PTSS | Week 4 (n=4, 3, 4) | 2.612 scores on a scale | Standard Error 0.788 |
| Pregabalin (300 mg) | Overall Pain Relief Measured by the PTSS | Week 2 (n=6, 4, 4) | 1.667 scores on a scale | Standard Error 0.675 |
| Placebo | Overall Pain Relief Measured by the PTSS | Week 6/ET (n=2, 5, 6) | 3.900 scores on a scale | Standard Error 0.797 |
| Placebo | Overall Pain Relief Measured by the PTSS | Week 2 (n=6, 4, 4) | 1.833 scores on a scale | Standard Error 0.893 |
| Placebo | Overall Pain Relief Measured by the PTSS | Week 4 (n=4, 3, 4) | 2.537 scores on a scale | Standard Error 0.73 |
| Placebo | Overall Pain Relief Measured by the PTSS | Discharge (n=12, 17, 15) | 2.051 scores on a scale | Standard Error 0.229 |
Comparison: Week 2p-value: 0.522695% CI: [-1.181, 2.181]ANOVA
Comparison: Week 2p-value: 0.855795% CI: [-2.156, 1.823]ANOVA
Comparison: Dischargep-value: 0.529995% CI: [-0.458, 0.874]ANOVA
Comparison: Dischargep-value: 0.244295% CI: [-0.964, 0.253]ANOVA
Comparison: Week 4p-value: 0.32495% CI: [-3.751, 1.512]ANOVA
Comparison: Week 4p-value: 0.950395% CI: [-2.853, 3.003]ANOVA
Comparison: Week 6/ETp-value: 0.361895% CI: [-6.379, 2.712]ANOVA
Comparison: Week 6/ETp-value: 0.722695% CI: [-1.859, 2.525]ANOVA
Secondary
Overall Satisfaction Measured by the PTSS
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Discharge, Week 2, Week 4, and Week 6/ET
Population: MITT.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Overall Satisfaction Measured by the PTSS | Discharge (n=12, 17, 15) | 1.845 scores on a scale | Standard Error 0.247 |
| Pregabalin (150 mg) | Overall Satisfaction Measured by the PTSS | Week 2 (n=6, 4, 4) | 2.333 scores on a scale | Standard Error 0.827 |
| Pregabalin (150 mg) | Overall Satisfaction Measured by the PTSS | Week 4 (n=4, 3, 4) | 1.149 scores on a scale | Standard Error 0.615 |
| Pregabalin (150 mg) | Overall Satisfaction Measured by the PTSS | Week 6/ET (n=2, 5, 6) | 1.526 scores on a scale | Standard Error 1.346 |
| Pregabalin (300 mg) | Overall Satisfaction Measured by the PTSS | Week 6/ET (n=2, 5, 6) | 4.174 scores on a scale | Standard Error 0.784 |
| Pregabalin (300 mg) | Overall Satisfaction Measured by the PTSS | Discharge (n=12, 17, 15) | 1.654 scores on a scale | Standard Error 0.202 |
| Pregabalin (300 mg) | Overall Satisfaction Measured by the PTSS | Week 4 (n=4, 3, 4) | 2.433 scores on a scale | Standard Error 0.679 |
| Pregabalin (300 mg) | Overall Satisfaction Measured by the PTSS | Week 2 (n=6, 4, 4) | 1.667 scores on a scale | Standard Error 0.675 |
| Placebo | Overall Satisfaction Measured by the PTSS | Week 6/ET (n=2, 5, 6) | 3.878 scores on a scale | Standard Error 0.765 |
| Placebo | Overall Satisfaction Measured by the PTSS | Week 2 (n=6, 4, 4) | 1.833 scores on a scale | Standard Error 0.893 |
| Placebo | Overall Satisfaction Measured by the PTSS | Week 4 (n=4, 3, 4) | 2.478 scores on a scale | Standard Error 0.629 |
| Placebo | Overall Satisfaction Measured by the PTSS | Discharge (n=12, 17, 15) | 1.821 scores on a scale | Standard Error 0.219 |
Comparison: Dischargep-value: 0.940595% CI: [-0.614, 0.661]ANOVA
Comparison: Dischargep-value: 0.564195% CI: [-0.749, 0.415]ANOVA
Comparison: Week 2p-value: 0.522695% CI: [-1.181, 2.181]ANOVA
Comparison: Week 2p-value: 0.855795% CI: [-2.156, 1.823]ANOVA
Comparison: Week 4p-value: 0.192595% CI: [-3.596, 0.94]ANOVA
Comparison: Week 4p-value: 0.965495% CI: [-2.568, 2.479]ANOVA
Comparison: Week 6/ETp-value: 0.23595% CI: [-6.712, 2.008]ANOVA
Comparison: Week 6/ETp-value: 0.74295% CI: [-1.806, 2.399]ANOVA
Secondary
Pain Interference Index Score as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.427 scores on a scale | Standard Error 0.23 |
| Pregabalin (150 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.969 scores on a scale | Standard Error 0.236 |
| Pregabalin (150 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.162 scores on a scale | Standard Error 0.202 |
| Pregabalin (150 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.597 scores on a scale | Standard Error 0.199 |
| Pregabalin (150 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.139 scores on a scale | Standard Error 0.367 |
| Pregabalin (150 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.513 scores on a scale | Standard Error 0.264 |
| Pregabalin (300 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.300 scores on a scale | Standard Error 0.241 |
| Pregabalin (300 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.488 scores on a scale | Standard Error 0.23 |
| Pregabalin (300 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.637 scores on a scale | Standard Error 0.214 |
| Pregabalin (300 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.335 scores on a scale | Standard Error 0.375 |
| Pregabalin (300 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.814 scores on a scale | Standard Error 0.245 |
| Pregabalin (300 mg) | Pain Interference Index Score as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.996 scores on a scale | Standard Error 0.208 |
| Placebo | Pain Interference Index Score as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.037 scores on a scale | Standard Error 0.251 |
| Placebo | Pain Interference Index Score as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.094 scores on a scale | Standard Error 0.224 |
| Placebo | Pain Interference Index Score as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 0.852 scores on a scale | Standard Error 0.253 |
| Placebo | Pain Interference Index Score as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.662 scores on a scale | Standard Error 0.215 |
| Placebo | Pain Interference Index Score as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.887 scores on a scale | Standard Error 0.246 |
| Placebo | Pain Interference Index Score as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.629 scores on a scale | Standard Error 0.366 |
Comparison: Dischargep-value: 0.153795% CI: [-1.093, 0.173]ANOVA
Comparison: Dischargep-value: 0.220895% CI: [-1.038, 0.241]ANOVA
Comparison: Week 2p-value: 0.835595% CI: [-0.707, 0.572]ANOVA
Comparison: Week 2p-value: 0.502495% CI: [-0.875, 0.43]ANOVA
Comparison: Week 4p-value: 0.811695% CI: [-0.489, 0.624]ANOVA
Comparison: Week 4p-value: 0.732595% CI: [-0.667, 0.469]ANOVA
Comparison: Week 6/ETp-value: 0.813395% CI: [-0.614, 0.482]ANOVA
Comparison: Week 6/ETp-value: 0.930795% CI: [-0.588, 0.538]ANOVA
Comparison: Month 3p-value: 0.268295% CI: [-1.364, 0.385]ANOVA
Comparison: Month 3p-value: 0.478495% CI: [-1.116, 0.528]ANOVA
Comparison: Month 6p-value: 0.025595% CI: [0.084, 1.239]ANOVA
Comparison: Month 6p-value: 0.159195% CI: [-0.18, 1.076]ANOVA
Secondary
Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.487 scores on a scale | Standard Error 0.33 |
| Pregabalin (150 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.945 scores on a scale | Standard Error 0.313 |
| Pregabalin (150 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.152 scores on a scale | Standard Error 0.26 |
| Pregabalin (150 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.535 scores on a scale | Standard Error 0.247 |
| Pregabalin (150 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 0.944 scores on a scale | Standard Error 0.497 |
| Pregabalin (150 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.657 scores on a scale | Standard Error 0.404 |
| Pregabalin (300 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.658 scores on a scale | Standard Error 0.367 |
| Pregabalin (300 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.769 scores on a scale | Standard Error 0.33 |
| Pregabalin (300 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.720 scores on a scale | Standard Error 0.266 |
| Pregabalin (300 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.467 scores on a scale | Standard Error 0.513 |
| Pregabalin (300 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.802 scores on a scale | Standard Error 0.325 |
| Pregabalin (300 mg) | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.042 scores on a scale | Standard Error 0.268 |
| Placebo | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.953 scores on a scale | Standard Error 0.334 |
| Placebo | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.768 scores on a scale | Standard Error 0.289 |
| Placebo | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 0.663 scores on a scale | Standard Error 0.389 |
| Placebo | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.696 scores on a scale | Standard Error 0.267 |
| Placebo | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.744 scores on a scale | Standard Error 0.354 |
| Placebo | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.368 scores on a scale | Standard Error 0.509 |
Comparison: Dischargep-value: 0.578695% CI: [-1.17, 0.655]ANOVA
Comparison: Dischargep-value: 0.95795% CI: [-0.895, 0.946]ANOVA
Comparison: Week 2p-value: 0.98695% CI: [-0.862, 0.847]ANOVA
Comparison: Week 2p-value: 0.733695% CI: [-1.021, 0.72]ANOVA
Comparison: Week 4p-value: 0.293995% CI: [-0.336, 1.104]ANOVA
Comparison: Week 4p-value: 0.461595% CI: [-0.459, 1.008]ANOVA
Comparison: Week 6/ETp-value: 0.643395% CI: [-0.845, 0.523]ANOVA
Comparison: Week 6/ETp-value: 0.946695% CI: [-0.678, 0.726]ANOVA
Comparison: Month 3p-value: 0.496795% CI: [-1.66, 0.812]ANOVA
Comparison: Month 3p-value: 0.865995% CI: [-1.06, 1.257]ANOVA
Comparison: Month 6p-value: 0.031195% CI: [0.093, 1.895]ANOVA
Comparison: Month 6p-value: 0.044195% CI: [0.027, 1.962]ANOVA
Secondary
Pain Interference With General Activity as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.794 scores on a scale | Standard Error 0.317 |
| Pregabalin (150 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.254 scores on a scale | Standard Error 0.278 |
| Pregabalin (150 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.470 scores on a scale | Standard Error 0.237 |
| Pregabalin (150 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 2.109 scores on a scale | Standard Error 0.245 |
| Pregabalin (150 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.861 scores on a scale | Standard Error 0.505 |
| Pregabalin (150 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.738 scores on a scale | Standard Error 0.412 |
| Pregabalin (300 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.717 scores on a scale | Standard Error 0.376 |
| Pregabalin (300 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 4.499 scores on a scale | Standard Error 0.315 |
| Pregabalin (300 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.902 scores on a scale | Standard Error 0.263 |
| Pregabalin (300 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.547 scores on a scale | Standard Error 0.507 |
| Pregabalin (300 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.526 scores on a scale | Standard Error 0.288 |
| Pregabalin (300 mg) | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.417 scores on a scale | Standard Error 0.244 |
| Placebo | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.524 scores on a scale | Standard Error 0.294 |
| Placebo | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.427 scores on a scale | Standard Error 0.26 |
| Placebo | Pain Interference With General Activity as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.410 scores on a scale | Standard Error 0.394 |
| Placebo | Pain Interference With General Activity as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 2.028 scores on a scale | Standard Error 0.263 |
| Placebo | Pain Interference With General Activity as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 4.764 scores on a scale | Standard Error 0.336 |
| Placebo | Pain Interference With General Activity as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.969 scores on a scale | Standard Error 0.492 |
Comparison: Dischargep-value: 0.028495% CI: [-1.835, -0.104]ANOVA
Comparison: Dischargep-value: 0.551695% CI: [-1.141, 0.611]ANOVA
Comparison: Week 2p-value: 0.47995% CI: [-1.02, 0.48]ANOVA
Comparison: Week 2p-value: 0.994795% CI: [-0.765, 0.77]ANOVA
Comparison: Week 4p-value: 0.894395% CI: [-0.605, 0.692]ANOVA
Comparison: Week 4p-value: 0.976795% CI: [-0.674, 0.654]ANOVA
Comparison: Week 6/ETp-value: 0.811795% CI: [-0.59, 0.752]ANOVA
Comparison: Week 6/ETp-value: 0.721695% CI: [-0.818, 0.567]ANOVA
Comparison: Month 3p-value: 0.855895% CI: [-1.286, 1.07]ANOVA
Comparison: Month 3p-value: 0.450195% CI: [-1.53, 0.685]ANOVA
Comparison: Month 6p-value: 0.468295% CI: [-0.57, 1.227]ANOVA
Comparison: Month 6p-value: 0.534795% CI: [-0.675, 1.289]ANOVA
Secondary
Pain Interference With Mood as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 2.588 scores on a scale | Standard Error 0.292 |
| Pregabalin (150 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.640 scores on a scale | Standard Error 0.292 |
| Pregabalin (150 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.590 scores on a scale | Standard Error 0.253 |
| Pregabalin (150 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.053 scores on a scale | Standard Error 0.23 |
| Pregabalin (150 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 0.632 scores on a scale | Standard Error 0.328 |
| Pregabalin (150 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.201 scores on a scale | Standard Error 0.326 |
| Pregabalin (300 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 0.832 scores on a scale | Standard Error 0.297 |
| Pregabalin (300 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 2.418 scores on a scale | Standard Error 0.291 |
| Pregabalin (300 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.171 scores on a scale | Standard Error 0.247 |
| Pregabalin (300 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 0.956 scores on a scale | Standard Error 0.339 |
| Pregabalin (300 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.115 scores on a scale | Standard Error 0.303 |
| Pregabalin (300 mg) | Pain Interference With Mood as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.511 scores on a scale | Standard Error 0.261 |
| Placebo | Pain Interference With Mood as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 2.554 scores on a scale | Standard Error 0.308 |
| Placebo | Pain Interference With Mood as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.530 scores on a scale | Standard Error 0.279 |
| Placebo | Pain Interference With Mood as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 0.369 scores on a scale | Standard Error 0.313 |
| Placebo | Pain Interference With Mood as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.325 scores on a scale | Standard Error 0.247 |
| Placebo | Pain Interference With Mood as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.354 scores on a scale | Standard Error 0.31 |
| Placebo | Pain Interference With Mood as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.334 scores on a scale | Standard Error 0.322 |
Comparison: Dischargep-value: 0.061395% CI: [-1.568, 0.037]ANOVA
Comparison: Dischargep-value: 0.02395% CI: [-1.741, -0.13]ANOVA
Comparison: Week 2p-value: 0.830695% CI: [-0.703, 0.875]ANOVA
Comparison: Week 2p-value: 0.281495% CI: [-1.242, 0.363]ANOVA
Comparison: Week 4p-value: 0.863795% CI: [-0.636, 0.757]ANOVA
Comparison: Week 4p-value: 0.958595% CI: [-0.727, 0.689]ANOVA
Comparison: Week 6/ETp-value: 0.397595% CI: [-0.906, 0.361]ANOVA
Comparison: Week 6/ETp-value: 0.638695% CI: [-0.799, 0.491]ANOVA
Comparison: Month 3p-value: 0.081395% CI: [-1.493, 0.089]ANOVA
Comparison: Month 3p-value: 0.3195% CI: [-1.114, 0.358]ANOVA
Comparison: Month 6p-value: 0.023195% CI: [0.118, 1.545]ANOVA
Comparison: Month 6p-value: 0.236795% CI: [-0.311, 1.237]ANOVA
Secondary
Pain Interference With Normal Work as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Discharge (n=82, 77, 72) | 4.879 scores on a scale | Standard Error 0.39 |
| Pregabalin (150 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 2 (n=86, 78, 79) | 4.010 scores on a scale | Standard Error 0.335 |
| Pregabalin (150 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.833 scores on a scale | Standard Error 0.275 |
| Pregabalin (150 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 2.133 scores on a scale | Standard Error 0.269 |
| Pregabalin (150 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.797 scores on a scale | Standard Error 0.51 |
| Pregabalin (150 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.627 scores on a scale | Standard Error 0.288 |
| Pregabalin (300 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.349 scores on a scale | Standard Error 0.263 |
| Pregabalin (300 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Discharge (n=82, 77, 72) | 4.738 scores on a scale | Standard Error 0.395 |
| Pregabalin (300 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 2.152 scores on a scale | Standard Error 0.291 |
| Pregabalin (300 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.731 scores on a scale | Standard Error 0.52 |
| Pregabalin (300 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 2 (n=86, 78, 79) | 3.539 scores on a scale | Standard Error 0.347 |
| Pregabalin (300 mg) | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.500 scores on a scale | Standard Error 0.285 |
| Placebo | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 2 (n=86, 78, 79) | 3.831 scores on a scale | Standard Error 0.355 |
| Placebo | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.895 scores on a scale | Standard Error 0.305 |
| Placebo | Pain Interference With Normal Work as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.029 scores on a scale | Standard Error 0.276 |
| Placebo | Pain Interference With Normal Work as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 2.040 scores on a scale | Standard Error 0.291 |
| Placebo | Pain Interference With Normal Work as Measured by the m-BPI-sf | Discharge (n=82, 77, 72) | 4.873 scores on a scale | Standard Error 0.418 |
| Placebo | Pain Interference With Normal Work as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 2.264 scores on a scale | Standard Error 0.507 |
Comparison: Dischargep-value: 0.991295% CI: [-1.07, 1.082]ANOVA
Comparison: Dischargep-value: 0.807695% CI: [-1.227, 0.957]ANOVA
Comparison: Week 2p-value: 0.697895% CI: [-0.727, 1.085]ANOVA
Comparison: Week 2p-value: 0.534495% CI: [-1.219, 0.634]ANOVA
Comparison: Week 4p-value: 0.872195% CI: [-0.819, 0.695]ANOVA
Comparison: Week 4p-value: 0.317995% CI: [-1.173, 0.383]ANOVA
Comparison: Week 6/ETp-value: 0.803795% CI: [-0.648, 0.835]ANOVA
Comparison: Week 6/ETp-value: 0.773195% CI: [-0.656, 0.881]ANOVA
Comparison: Month 3p-value: 0.446195% CI: [-1.684, 0.748]ANOVA
Comparison: Month 3p-value: 0.356895% CI: [-1.679, 0.612]ANOVA
Comparison: Month 6p-value: 0.062395% CI: [-0.032, 1.227]ANOVA
Comparison: Month 6p-value: 0.352995% CI: [-0.364, 1.005]ANOVA
Secondary
Pain Interference With Relations With People as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 1.837 scores on a scale | Standard Error 0.266 |
| Pregabalin (150 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 1.566 scores on a scale | Standard Error 0.231 |
| Pregabalin (150 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.004 scores on a scale | Standard Error 0.215 |
| Pregabalin (150 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 0.544 scores on a scale | Standard Error 0.171 |
| Pregabalin (150 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 0.253 scores on a scale | Standard Error 0.377 |
| Pregabalin (150 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 0.802 scores on a scale | Standard Error 0.245 |
| Pregabalin (300 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.060 scores on a scale | Standard Error 0.226 |
| Pregabalin (300 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 1.716 scores on a scale | Standard Error 0.266 |
| Pregabalin (300 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 0.845 scores on a scale | Standard Error 0.184 |
| Pregabalin (300 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 0.861 scores on a scale | Standard Error 0.377 |
| Pregabalin (300 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 1.370 scores on a scale | Standard Error 0.24 |
| Pregabalin (300 mg) | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.162 scores on a scale | Standard Error 0.222 |
| Placebo | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 1.671 scores on a scale | Standard Error 0.246 |
| Placebo | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 1.187 scores on a scale | Standard Error 0.238 |
| Placebo | Pain Interference With Relations With People as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 0.626 scores on a scale | Standard Error 0.235 |
| Placebo | Pain Interference With Relations With People as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 0.898 scores on a scale | Standard Error 0.185 |
| Placebo | Pain Interference With Relations With People as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 2.624 scores on a scale | Standard Error 0.284 |
| Placebo | Pain Interference With Relations With People as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.364 scores on a scale | Standard Error 0.365 |
Comparison: Dischargep-value: 0.035995% CI: [-1.52, -0.052]ANOVA
Comparison: Dischargep-value: 0.016195% CI: [-1.644, -0.17]ANOVA
Comparison: Week 2p-value: 0.741695% CI: [-0.733, 0.523]ANOVA
Comparison: Week 2p-value: 0.352795% CI: [-0.939, 0.336]ANOVA
Comparison: Week 4p-value: 0.541995% CI: [-0.776, 0.409]ANOVA
Comparison: Week 4p-value: 0.933395% CI: [-0.628, 0.577]ANOVA
Comparison: Week 6/ETp-value: 0.14295% CI: [-0.827, 0.12]ANOVA
Comparison: Week 6/ETp-value: 0.82995% CI: [-0.535, 0.429]ANOVA
Comparison: Month 3p-value: 0.013895% CI: [-1.989, -0.233]ANOVA
Comparison: Month 3p-value: 0.2395% CI: [-1.332, 0.325]ANOVA
Comparison: Month 6p-value: 0.515195% CI: [-0.36, 0.711]ANOVA
Comparison: Month 6p-value: 0.14695% CI: [-0.155, 1.022]ANOVA
Secondary
Pain Interference With Sleep as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 2.696 scores on a scale | Standard Error 0.299 |
| Pregabalin (150 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.139 scores on a scale | Standard Error 0.333 |
| Pregabalin (150 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.478 scores on a scale | Standard Error 0.278 |
| Pregabalin (150 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.847 scores on a scale | Standard Error 0.275 |
| Pregabalin (150 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.276 scores on a scale | Standard Error 0.537 |
| Pregabalin (150 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.963 scores on a scale | Standard Error 0.482 |
| Pregabalin (300 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.005 scores on a scale | Standard Error 0.439 |
| Pregabalin (300 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 2.642 scores on a scale | Standard Error 0.299 |
| Pregabalin (300 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.701 scores on a scale | Standard Error 0.296 |
| Pregabalin (300 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 0.941 scores on a scale | Standard Error 0.548 |
| Pregabalin (300 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.015 scores on a scale | Standard Error 0.345 |
| Pregabalin (300 mg) | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.166 scores on a scale | Standard Error 0.288 |
| Placebo | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.587 scores on a scale | Standard Error 0.353 |
| Placebo | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.668 scores on a scale | Standard Error 0.308 |
| Placebo | Pain Interference With Sleep as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 0.778 scores on a scale | Standard Error 0.464 |
| Placebo | Pain Interference With Sleep as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 2.070 scores on a scale | Standard Error 0.296 |
| Placebo | Pain Interference With Sleep as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 3.307 scores on a scale | Standard Error 0.318 |
| Placebo | Pain Interference With Sleep as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.499 scores on a scale | Standard Error 0.526 |
Comparison: Week 2p-value: 0.328595% CI: [-1.35, 0.454]ANOVA
Comparison: Week 2p-value: 0.220595% CI: [-1.49, 0.346]ANOVA
Comparison: Dischargep-value: 0.144895% CI: [-1.434, 0.212]ANOVA
Comparison: Dischargep-value: 0.114895% CI: [-1.494, 0.163]ANOVA
Comparison: Week 4p-value: 0.626695% CI: [-0.958, 0.578]ANOVA
Comparison: Week 4p-value: 0.207795% CI: [-1.284, 0.281]ANOVA
Comparison: Week 6/ETp-value: 0.562695% CI: [-0.982, 0.536]ANOVA
Comparison: Week 6/ETp-value: 0.350795% CI: [-1.145, 0.408]ANOVA
Comparison: Month 3p-value: 0.727695% CI: [-1.498, 1.05]ANOVA
Comparison: Month 3p-value: 0.35395% CI: [-1.748, 0.631]ANOVA
Comparison: Month 6p-value: 0.028395% CI: [0.13, 2.242]ANOVA
Comparison: Month 6p-value: 0.693495% CI: [-0.918, 1.372]ANOVA
Secondary
Pain Interference With Walking Ability as Measured by the m-BPI-sf
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes.
Time frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 4.918 scores on a scale | Standard Error 0.32 |
| Pregabalin (150 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.297 scores on a scale | Standard Error 0.278 |
| Pregabalin (150 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.646 scores on a scale | Standard Error 0.259 |
| Pregabalin (150 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 2.004 scores on a scale | Standard Error 0.237 |
| Pregabalin (150 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.439 scores on a scale | Standard Error 0.419 |
| Pregabalin (150 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.573 scores on a scale | Standard Error 0.322 |
| Pregabalin (300 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.391 scores on a scale | Standard Error 0.293 |
| Pregabalin (300 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 4.728 scores on a scale | Standard Error 0.319 |
| Pregabalin (300 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.886 scores on a scale | Standard Error 0.254 |
| Pregabalin (300 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.907 scores on a scale | Standard Error 0.434 |
| Pregabalin (300 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.344 scores on a scale | Standard Error 0.289 |
| Pregabalin (300 mg) | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.108 scores on a scale | Standard Error 0.267 |
| Placebo | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 2 (n=86, 78, 80) | 3.425 scores on a scale | Standard Error 0.296 |
| Placebo | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 4 (n=77, 69, 67) | 2.442 scores on a scale | Standard Error 0.286 |
| Placebo | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Month 6 (n=31, 25, 27) | 1.126 scores on a scale | Standard Error 0.308 |
| Placebo | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Week 6/ET (n=78, 67, 71) | 1.742 scores on a scale | Standard Error 0.256 |
| Placebo | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Discharge (n=83, 80, 74) | 4.982 scores on a scale | Standard Error 0.342 |
| Placebo | Pain Interference With Walking Ability as Measured by the m-BPI-sf | Month 3 (n=30, 32, 35) | 1.928 scores on a scale | Standard Error 0.414 |
Comparison: Dischargep-value: 0.886895% CI: [-0.947, 0.82]ANOVA
Comparison: Dischargep-value: 0.573395% CI: [-1.142, 0.634]ANOVA
Comparison: Week 2p-value: 0.738595% CI: [-0.884, 0.628]ANOVA
Comparison: Week 2p-value: 0.835395% CI: [-0.849, 0.687]ANOVA
Comparison: Week 4p-value: 0.573795% CI: [-0.51, 0.918]ANOVA
Comparison: Week 4p-value: 0.36495% CI: [-1.06, 0.391]ANOVA
Comparison: Week 6/ETp-value: 0.431595% CI: [-0.393, 0.917]ANOVA
Comparison: Week 6/ETp-value: 0.672795% CI: [-0.525, 0.812]ANOVA
Comparison: Month 3p-value: 0.336195% CI: [-1.496, 0.517]ANOVA
Comparison: Month 3p-value: 0.963495% CI: [-0.955, 0.912]ANOVA
Comparison: Month 6p-value: 0.209895% CI: [-0.257, 1.15]ANOVA
Comparison: Month 6p-value: 0.4995% CI: [-0.497, 1.027]ANOVA
Secondary
Pain-Related Sleep Interference Post Surgery
The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge.
Time frame: 24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | 24 hours (n=86, 86, 81) | 4.452 scores on a scale | Standard Error 0.359 |
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | 48 hours (n=82, 82, 77) | 3.830 scores on a scale | Standard Error 0.293 |
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | 72 hours (n=59, 58, 59) | 2.926 scores on a scale | Standard Error 0.332 |
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | 96 hours (n=20, 21, 24) | 4.087 scores on a scale | Standard Error 0.539 |
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | 120 hours (n=6, 4, 7) | 3.194 scores on a scale | Standard Error 1.665 |
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | Week 2 (n=80, 73, 71) | 3.837 scores on a scale | Standard Error 0.217 |
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | Week 4 (n=76, 65, 67) | 3.181 scores on a scale | Standard Error 0.216 |
| Pregabalin (150 mg) | Pain-Related Sleep Interference Post Surgery | Week 6/ET (n=61, 56, 57) | 2.484 scores on a scale | Standard Error 0.261 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | 72 hours (n=59, 58, 59) | 2.609 scores on a scale | Standard Error 0.349 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | Week 4 (n=76, 65, 67) | 3.042 scores on a scale | Standard Error 0.236 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | 96 hours (n=20, 21, 24) | 1.645 scores on a scale | Standard Error 0.522 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | 120 hours (n=6, 4, 7) | 7.237 scores on a scale | Standard Error 2.563 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | Week 2 (n=80, 73, 71) | 4.128 scores on a scale | Standard Error 0.229 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | 24 hours (n=86, 86, 81) | 3.671 scores on a scale | Standard Error 0.364 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | 48 hours (n=82, 82, 77) | 3.408 scores on a scale | Standard Error 0.296 |
| Pregabalin (300 mg) | Pain-Related Sleep Interference Post Surgery | Week 6/ET (n=61, 56, 57) | 2.592 scores on a scale | Standard Error 0.265 |
| Placebo | Pain-Related Sleep Interference Post Surgery | 72 hours (n=59, 58, 59) | 3.645 scores on a scale | Standard Error 0.345 |
| Placebo | Pain-Related Sleep Interference Post Surgery | 48 hours (n=82, 82, 77) | 4.027 scores on a scale | Standard Error 0.309 |
| Placebo | Pain-Related Sleep Interference Post Surgery | 24 hours (n=86, 86, 81) | 5.481 scores on a scale | Standard Error 0.376 |
| Placebo | Pain-Related Sleep Interference Post Surgery | 96 hours (n=20, 21, 24) | 3.213 scores on a scale | Standard Error 0.563 |
| Placebo | Pain-Related Sleep Interference Post Surgery | Week 4 (n=76, 65, 67) | 3.532 scores on a scale | Standard Error 0.241 |
| Placebo | Pain-Related Sleep Interference Post Surgery | Week 2 (n=80, 73, 71) | 4.256 scores on a scale | Standard Error 0.239 |
| Placebo | Pain-Related Sleep Interference Post Surgery | 120 hours (n=6, 4, 7) | 1.328 scores on a scale | Standard Error 1.598 |
| Placebo | Pain-Related Sleep Interference Post Surgery | Week 6/ET (n=61, 56, 57) | 2.748 scores on a scale | Standard Error 0.284 |
Comparison: 24 hoursp-value: 0.038895% CI: [-2.004, -0.053]ANOVA
Comparison: 24 hoursp-value: 0.000495% CI: [-2.798, -0.822]ANOVA
Comparison: 48 hoursp-value: 0.627495% CI: [-0.995, 0.601]ANOVA
Comparison: 48 hoursp-value: 0.13595% CI: [-1.432, 0.194]ANOVA
Comparison: 72 hoursp-value: 0.110695% CI: [-1.605, 0.166]ANOVA
Comparison: 72 hoursp-value: 0.024895% CI: [-1.939, -0.133]ANOVA
Comparison: 96 hoursp-value: 0.233595% CI: [-0.582, 2.33]ANOVA
Comparison: 96 hoursp-value: 0.025895% CI: [-2.939, -0.198]ANOVA
Comparison: 120 hoursp-value: 0.387895% CI: [-3.207, 6.939]ANOVA
Comparison: 120 hoursp-value: 0.176295% CI: [-3.74, 15.559]ANOVA
Comparison: Dischargep-value: 0.175495% CI: [-1.261, 0.231]ANOVA
Comparison: Dischargep-value: 0.141395% CI: [-1.329, 0.191]ANOVA
Comparison: Week 2p-value: 0.173195% CI: [-1.023, 0.185]ANOVA
Comparison: Week 2p-value: 0.682995% CI: [-0.747, 0.49]ANOVA
Comparison: Week 4p-value: 0.243695% CI: [-0.943, 0.241]ANOVA
Comparison: Week 4p-value: 0.11995% CI: [-1.108, 0.127]ANOVA
Comparison: Week 6/ETp-value: 0.411795% CI: [-0.897, 0.369]ANOVA
Comparison: Week 6/ETp-value: 0.629495% CI: [-0.794, 0.482]ANOVA
Secondary
Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee
The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer.
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 24 hours (n=74, 71, 68) | 54.877 degrees | Standard Error 2.194 |
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 48 hours (n=76, 78, 67) | 69.981 degrees | Standard Error 1.984 |
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 72 hours (n=52, 52, 50) | 76.516 degrees | Standard Error 2.274 |
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 96 hours (n=17, 17, 24) | 78.624 degrees | Standard Error 3.287 |
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 120 hours (n=6, 3, 6) | 80.694 degrees | Standard Error 4.89 |
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 2 (n=73, 67, 69) | 89.917 degrees | Standard Error 1.589 |
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 4 (n=65, 63, 62) | 98.883 degrees | Standard Error 1.87 |
| Pregabalin (150 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 6/ET (n=67, 54, 63) | 105.352 degrees | Standard Error 1.845 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 72 hours (n=52, 52, 50) | 79.535 degrees | Standard Error 2.348 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 4 (n=65, 63, 62) | 102.237 degrees | Standard Error 1.914 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 96 hours (n=17, 17, 24) | 79.500 degrees | Standard Error 2.936 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 120 hours (n=6, 3, 6) | 72.694 degrees | Standard Error 7.881 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 2 (n=73, 67, 69) | 90.332 degrees | Standard Error 1.656 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 24 hours (n=74, 71, 68) | 60.744 degrees | Standard Error 2.248 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 48 hours (n=76, 78, 67) | 73.370 degrees | Standard Error 1.967 |
| Pregabalin (300 mg) | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 6/ET (n=67, 54, 63) | 106.252 degrees | Standard Error 2.137 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 72 hours (n=52, 52, 50) | 75.588 degrees | Standard Error 2.406 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 48 hours (n=76, 78, 67) | 69.178 degrees | Standard Error 2.184 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 24 hours (n=74, 71, 68) | 55.738 degrees | Standard Error 2.287 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 96 hours (n=17, 17, 24) | 74.194 degrees | Standard Error 2.969 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 4 (n=65, 63, 62) | 96.921 degrees | Standard Error 2.017 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 2 (n=73, 67, 69) | 87.992 degrees | Standard Error 1.711 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | 120 hours (n=6, 3, 6) | 81.765 degrees | Standard Error 5.625 |
| Placebo | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee | Week 6/ET (n=67, 54, 63) | 103.980 degrees | Standard Error 2.051 |
Comparison: 24 hoursp-value: 0.774295% CI: [-6.775, 5.052]ANOVA
Comparison: 24 hoursp-value: 0.099695% CI: [-0.96, 10.971]ANOVA
Comparison: 48 hoursp-value: 0.773895% CI: [-4.698, 6.304]ANOVA
Comparison: 48 hoursp-value: 0.132895% CI: [-1.284, 9.669]ANOVA
Comparison: 72 hoursp-value: 0.758595% CI: [-5.027, 6.882]ANOVA
Comparison: 72 hoursp-value: 0.1995% CI: [-1.979, 9.871]ANOVA
Comparison: 96 hoursp-value: 0.236595% CI: [-3.004, 11.865]ANOVA
Comparison: 96 hoursp-value: 0.161695% CI: [-2.202, 12.814]ANOVA
Comparison: 120 hoursp-value: 0.881995% CI: [-17.98, 15.838]ANOVA
Comparison: 120 hoursp-value: 0.467695% CI: [-37.7, 19.558]ANOVA
Comparison: Week 2p-value: 0.381395% CI: [-2.403, 6.254]ANOVA
Comparison: Week 2p-value: 0.296695% CI: [-2.07, 6.751]ANOVA
Comparison: Week 4p-value: 0.447495% CI: [-3.122, 7.046]ANOVA
Comparison: Week 4p-value: 0.041695% CI: [0.204, 10.427]ANOVA
Comparison: Week 6/ETp-value: 0.593595% CI: [-3.694, 6.438]ANOVA
Comparison: Week 6/ETp-value: 0.396695% CI: [-3.006, 7.551]ANOVA
Secondary
ROM Assessment of the Passive Flexion of the Surgical Knee
The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer.
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 24 hours (n=81, 76, 73) | 66.720 degrees | Standard Error 1.99 |
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 48 hours (n=78, 80, 70) | 77.714 degrees | Standard Error 1.695 |
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 72 hours (n=53, 50, 53) | 84.154 degrees | Standard Error 1.952 |
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 96 hours (n=17, 17, 24) | 86.471 degrees | Standard Error 3.553 |
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 120 hours (n=5, 3, 6) | 92.160 degrees | Standard Error 1.517 |
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 2 (n=79, 71, 73) | 94.767 degrees | Standard Error 1.52 |
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 4 (n=72, 62, 65) | 104.548 degrees | Standard Error 1.68 |
| Pregabalin (150 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 6/ET (n=74, 60, 66) | 110.318 degrees | Standard Error 1.629 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 72 hours (n=53, 50, 53) | 88.119 degrees | Standard Error 2.041 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 4 (n=72, 62, 65) | 107.703 degrees | Standard Error 1.835 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 96 hours (n=17, 17, 24) | 91.460 degrees | Standard Error 3.174 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 120 hours (n=5, 3, 6) | 97.160 degrees | Standard Error 2.381 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 2 (n=79, 71, 73) | 96.973 degrees | Standard Error 1.606 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 24 hours (n=81, 76, 73) | 71.523 degrees | Standard Error 2.098 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | 48 hours (n=78, 80, 70) | 81.322 degrees | Standard Error 1.675 |
| Pregabalin (300 mg) | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 6/ET (n=74, 60, 66) | 111.348 degrees | Standard Error 1.884 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | 72 hours (n=53, 50, 53) | 80.984 degrees | Standard Error 1.971 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | 48 hours (n=78, 80, 70) | 76.813 degrees | Standard Error 1.809 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | 24 hours (n=81, 76, 73) | 64.991 degrees | Standard Error 2.093 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | 96 hours (n=17, 17, 24) | 80.287 degrees | Standard Error 3.21 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 4 (n=72, 62, 65) | 101.932 degrees | Standard Error 1.851 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 2 (n=79, 71, 73) | 93.642 degrees | Standard Error 1.647 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | 120 hours (n=5, 3, 6) | 79.218 degrees | Standard Error 1.682 |
| Placebo | ROM Assessment of the Passive Flexion of the Surgical Knee | Week 6/ET (n=74, 60, 66) | 108.944 degrees | Standard Error 1.848 |
Comparison: 24 hoursp-value: 0.511795% CI: [-3.457, 6.916]ANOVA
Comparison: 24 hoursp-value: 0.015495% CI: [1.258, 11.805]ANOVA
Comparison: 48 hoursp-value: 0.702295% CI: [-3.738, 5.54]ANOVA
Comparison: 48 hoursp-value: 0.055795% CI: [-0.11, 9.129]ANOVA
Comparison: 72 hoursp-value: 0.216195% CI: [-1.874, 8.215]ANOVA
Comparison: 72 hoursp-value: 0.005895% CI: [2.098, 12.172]ANOVA
Comparison: 96 hoursp-value: 0.128395% CI: [-1.853, 14.223]ANOVA
Comparison: 96 hoursp-value: 0.00895% CI: [3.056, 19.291]ANOVA
Comparison: 120 hoursp-value: 0.001895% CI: [7.414, 18.468]ANOVA
Comparison: 120 hoursp-value: 0.003895% CI: [8.859, 27.023]ANOVA
Comparison: Week 2p-value: 0.595395% CI: [-3.045, 5.296]ANOVA
Comparison: Week 2p-value: 0.126795% CI: [-0.952, 7.613]ANOVA
Comparison: Week 4p-value: 0.264795% CI: [-1.997, 7.231]ANOVA
Comparison: Week 4p-value: 0.018195% CI: [0.995, 10.548]ANOVA
Comparison: Week 6/ETp-value: 0.550795% CI: [-3.161, 5.91]ANOVA
Comparison: Week 6/ETp-value: 0.316495% CI: [-2.317, 7.124]ANOVA
Secondary
Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Discharge, Week 2, Week 4, Week 6/ET
Population: MITT.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Discharge (n=84, 84, 80) | 79.897 scores on a scale | Standard Error 1.802 |
| Pregabalin (150 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 2 (n=22, 20, 18) | 85.274 scores on a scale | Standard Error 4.689 |
| Pregabalin (150 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 4 (n=30, 27, 19) | 83.608 scores on a scale | Standard Error 3.012 |
| Pregabalin (150 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 6/ET (n=32, 31, 40) | 74.618 scores on a scale | Standard Error 3.922 |
| Pregabalin (300 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 6/ET (n=32, 31, 40) | 76.925 scores on a scale | Standard Error 4.187 |
| Pregabalin (300 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Discharge (n=84, 84, 80) | 80.706 scores on a scale | Standard Error 1.809 |
| Pregabalin (300 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 4 (n=30, 27, 19) | 84.728 scores on a scale | Standard Error 3.01 |
| Pregabalin (300 mg) | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 2 (n=22, 20, 18) | 85.294 scores on a scale | Standard Error 4.782 |
| Placebo | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 6/ET (n=32, 31, 40) | 71.962 scores on a scale | Standard Error 4.044 |
| Placebo | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 2 (n=22, 20, 18) | 80.148 scores on a scale | Standard Error 5.201 |
| Placebo | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Week 4 (n=30, 27, 19) | 81.572 scores on a scale | Standard Error 3.765 |
| Placebo | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) | Discharge (n=84, 84, 80) | 77.550 scores on a scale | Standard Error 1.89 |
Comparison: Dischargep-value: 0.348395% CI: [-2.573, 7.268]ANOVA
Comparison: Dischargep-value: 0.207895% CI: [-1.766, 8.077]ANOVA
Comparison: Week 2p-value: 0.429995% CI: [-7.836, 18.088]ANOVA
Comparison: Week 2p-value: 0.448295% CI: [-8.4, 18.693]ANOVA
Comparison: Week 4p-value: 0.647295% CI: [-6.818, 10.89]ANOVA
Comparison: Week 4p-value: 0.499295% CI: [-6.129, 12.442]ANOVA
Comparison: Week 6/ETp-value: 0.607295% CI: [-7.578, 12.891]ANOVA
Comparison: Week 6/ETp-value: 0.314695% CI: [-4.789, 14.714]ANOVA
Secondary
Satisfaction With Medication Characteristics Measured by the PTSS
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Discharge, Week 2, Week 4, Week 6/ET
Population: MITT.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Discharge (n=84, 84, 80) | 85.733 scores on a scale | Standard Error 1.679 |
| Pregabalin (150 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Week 2 (n=22, 20, 18) | 91.880 scores on a scale | Standard Error 4.676 |
| Pregabalin (150 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Week 4 (n=30, 27, 19) | 88.492 scores on a scale | Standard Error 2.693 |
| Pregabalin (150 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Week 6/ET (n=32, 31, 40) | 82.339 scores on a scale | Standard Error 3.729 |
| Pregabalin (300 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Week 6/ET (n=32, 31, 40) | 84.571 scores on a scale | Standard Error 3.98 |
| Pregabalin (300 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Discharge (n=84, 84, 80) | 85.732 scores on a scale | Standard Error 1.685 |
| Pregabalin (300 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Week 4 (n=30, 27, 19) | 90.571 scores on a scale | Standard Error 2.691 |
| Pregabalin (300 mg) | Satisfaction With Medication Characteristics Measured by the PTSS | Week 2 (n=22, 20, 18) | 87.869 scores on a scale | Standard Error 4.769 |
| Placebo | Satisfaction With Medication Characteristics Measured by the PTSS | Week 6/ET (n=32, 31, 40) | 76.908 scores on a scale | Standard Error 3.845 |
| Placebo | Satisfaction With Medication Characteristics Measured by the PTSS | Week 2 (n=22, 20, 18) | 84.583 scores on a scale | Standard Error 5.187 |
| Placebo | Satisfaction With Medication Characteristics Measured by the PTSS | Week 4 (n=30, 27, 19) | 84.323 scores on a scale | Standard Error 3.366 |
| Placebo | Satisfaction With Medication Characteristics Measured by the PTSS | Discharge (n=84, 84, 80) | 81.556 scores on a scale | Standard Error 1.761 |
Comparison: Dischargep-value: 0.073995% CI: [-0.407, 8.76]ANOVA
Comparison: Dischargep-value: 0.07495% CI: [-0.409, 8.761]ANOVA
Comparison: Week 2p-value: 0.261595% CI: [-5.628, 20.224]ANOVA
Comparison: Week 2p-value: 0.626695% CI: [-10.22, 16.795]ANOVA
Comparison: Week 4p-value: 0.296395% CI: [-3.747, 12.086]ANOVA
Comparison: Week 4p-value: 0.137595% CI: [-2.054, 14.55]ANOVA
Comparison: Week 6/ETp-value: 0.270395% CI: [-4.298, 15.161]ANOVA
Comparison: Week 6/ETp-value: 0.10495% CI: [-1.607, 16.933]ANOVA
Secondary
Satisfaction With Medication Efficacy Measured by the PTSS
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time frame: Discharge, Week 2, Week 4, Week 6/ET
Population: MITT.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Discharge (n=84, 84, 80) | 74.156 scores on a scale | Standard Error 2.276 |
| Pregabalin (150 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Week 2 (n=22, 20, 18) | 78.669 scores on a scale | Standard Error 6.01 |
| Pregabalin (150 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Week 4 (n=30, 27, 19) | 78.723 scores on a scale | Standard Error 3.811 |
| Pregabalin (150 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Week 6/ET (n=32, 31, 40) | 66.887 scores on a scale | Standard Error 4.958 |
| Pregabalin (300 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Week 6/ET (n=32, 31, 40) | 69.367 scores on a scale | Standard Error 5.292 |
| Pregabalin (300 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Discharge (n=84, 84, 80) | 75.705 scores on a scale | Standard Error 2.284 |
| Pregabalin (300 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Week 4 (n=30, 27, 19) | 78.886 scores on a scale | Standard Error 3.808 |
| Pregabalin (300 mg) | Satisfaction With Medication Efficacy Measured by the PTSS | Week 2 (n=22, 20, 18) | 82.724 scores on a scale | Standard Error 6.129 |
| Placebo | Satisfaction With Medication Efficacy Measured by the PTSS | Week 6/ET (n=32, 31, 40) | 67.015 scores on a scale | Standard Error 5.112 |
| Placebo | Satisfaction With Medication Efficacy Measured by the PTSS | Week 2 (n=22, 20, 18) | 75.713 scores on a scale | Standard Error 6.666 |
| Placebo | Satisfaction With Medication Efficacy Measured by the PTSS | Week 4 (n=30, 27, 19) | 78.823 scores on a scale | Standard Error 4.763 |
| Placebo | Satisfaction With Medication Efficacy Measured by the PTSS | Discharge (n=84, 84, 80) | 73.577 scores on a scale | Standard Error 2.387 |
Comparison: Dischargep-value: 0.854595% CI: [-5.635, 6.793]ANOVA
Comparison: Dischargep-value: 0.500695% CI: [-4.088, 8.344]ANOVA
Comparison: Week 2p-value: 0.721795% CI: [-13.66, 19.569]ANOVA
Comparison: Week 2p-value: 0.420395% CI: [-10.35, 24.372]ANOVA
Comparison: Week 4p-value: 0.985995% CI: [-11.3, 11.102]ANOVA
Comparison: Week 4p-value: 0.991595% CI: [-11.68, 11.811]ANOVA
Comparison: Week 6/ETp-value: 0.984395% CI: [-13.06, 12.808]ANOVA
Comparison: Week 6/ETp-value: 0.705595% CI: [-9.974, 14.677]ANOVA
Secondary
The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score
The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent).
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
Population: MITT.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 96 hours (n=49, 53, 54) | 0.623 scores on a scale | Standard Error 0.087 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 6/ET (n=78, 66, 71) | 0.249 scores on a scale | Standard Error 0.043 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Discharge (n=86, 85, 81) | 0.567 scores on a scale | Standard Error 0.056 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 120 hours (n=19, 17, 23) | 0.427 scores on a scale | Standard Error 0.086 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 24 hours (n=72, 69, 69) | 0.767 scores on a scale | Standard Error 0.069 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 4 (n=77, 69, 67) | 0.402 scores on a scale | Standard Error 0.048 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 72 hours (n=81, 77, 73) | 0.669 scores on a scale | Standard Error 0.064 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 48 hours (n=83, 86, 76) | 0.782 scores on a scale | Standard Error 0.061 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 2 (n=87, 78, 79) | 0.535 scores on a scale | Standard Error 0.056 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 120 hours (n=19, 17, 23) | 0.405 scores on a scale | Standard Error 0.087 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 24 hours (n=72, 69, 69) | 0.808 scores on a scale | Standard Error 0.072 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 48 hours (n=83, 86, 76) | 0.779 scores on a scale | Standard Error 0.06 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 72 hours (n=81, 77, 73) | 0.688 scores on a scale | Standard Error 0.066 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 96 hours (n=49, 53, 54) | 0.656 scores on a scale | Standard Error 0.083 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Discharge (n=86, 85, 81) | 0.619 scores on a scale | Standard Error 0.056 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 2 (n=87, 78, 79) | 0.525 scores on a scale | Standard Error 0.058 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 4 (n=77, 69, 67) | 0.415 scores on a scale | Standard Error 0.05 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 6/ET (n=78, 66, 71) | 0.386 scores on a scale | Standard Error 0.047 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 72 hours (n=81, 77, 73) | 0.726 scores on a scale | Standard Error 0.069 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 24 hours (n=72, 69, 69) | 0.888 scores on a scale | Standard Error 0.074 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 2 (n=87, 78, 79) | 0.513 scores on a scale | Standard Error 0.059 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 48 hours (n=83, 86, 76) | 0.908 scores on a scale | Standard Error 0.063 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 6/ET (n=78, 66, 71) | 0.239 scores on a scale | Standard Error 0.047 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 120 hours (n=19, 17, 23) | 0.446 scores on a scale | Standard Error 0.087 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | 96 hours (n=49, 53, 54) | 0.676 scores on a scale | Standard Error 0.082 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Week 4 (n=77, 69, 67) | 0.391 scores on a scale | Standard Error 0.053 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score | Discharge (n=86, 85, 81) | 0.664 scores on a scale | Standard Error 0.058 |
Comparison: 24 hoursp-value: 0.166195% CI: [-0.293, 0.051]ANOVA
Comparison: 24 hoursp-value: 0.360495% CI: [-0.254, 0.093]ANOVA
Comparison: 48 hoursp-value: 0.129995% CI: [-0.29, 0.037]ANOVA
Comparison: 48 hoursp-value: 0.116795% CI: [-0.29, 0.032]ANOVA
Comparison: 72 hoursp-value: 0.527195% CI: [-0.234, 0.12]ANOVA
Comparison: 72 hoursp-value: 0.673195% CI: [-0.215, 0.139]ANOVA
Comparison: 96 hoursp-value: 0.593695% CI: [-0.247, 0.142]ANOVA
Comparison: 96 hoursp-value: 0.836895% CI: [-0.206, 0.167]ANOVA
Comparison: 120 hoursp-value: 0.865995% CI: [-0.242, 0.204]ANOVA
Comparison: 120 hoursp-value: 0.715195% CI: [-0.266, 0.184]ANOVA
Comparison: Dischargep-value: 0.212195% CI: [-0.249, 0.056]ANOVA
Comparison: Dischargep-value: 0.560795% CI: [-0.197, 0.107]ANOVA
Comparison: Week 2p-value: 0.779795% CI: [-0.13, 0.173]ANOVA
Comparison: Week 2p-value: 0.876195% CI: [-0.143, 0.167]ANOVA
Comparison: Week 4p-value: 0.861995% CI: [-0.121, 0.144]ANOVA
Comparison: Week 4p-value: 0.725695% CI: [-0.111, 0.159]ANOVA
Comparison: Week 6/ETp-value: 0.865995% CI: [-0.11, 0.131]ANOVA
Comparison: Week 6/ETp-value: 0.020395% CI: [0.023, 0.27]ANOVA
Secondary
The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score
The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother).
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 96 hours (n=49, 53, 54) | 0.572 scores on a scale | Standard Error 0.096 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 6/ET (n=78, 66, 71) | 0.260 scores on a scale | Standard Error 0.049 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Discharge (n=86, 85, 82) | 0.575 scores on a scale | Standard Error 0.067 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 120 hours (n=19, 17, 23) | 0.565 scores on a scale | Standard Error 0.111 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 24 hours (n=72, 69, 69) | 0.671 scores on a scale | Standard Error 0.081 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 4 (n=77, 69, 67) | 0.395 scores on a scale | Standard Error 0.053 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 72 hours (n=81, 77, 73) | 0.686 scores on a scale | Standard Error 0.077 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 48 hours (n=83, 86, 77) | 0.810 scores on a scale | Standard Error 0.067 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 2 (n=87, 78, 79) | 0.527 scores on a scale | Standard Error 0.063 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 120 hours (n=19, 17, 23) | 0.439 scores on a scale | Standard Error 0.113 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 24 hours (n=72, 69, 69) | 0.788 scores on a scale | Standard Error 0.084 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 48 hours (n=83, 86, 77) | 0.769 scores on a scale | Standard Error 0.066 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 72 hours (n=81, 77, 73) | 0.694 scores on a scale | Standard Error 0.08 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 96 hours (n=49, 53, 54) | 0.623 scores on a scale | Standard Error 0.092 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Discharge (n=86, 85, 82) | 0.616 scores on a scale | Standard Error 0.067 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 2 (n=87, 78, 79) | 0.506 scores on a scale | Standard Error 0.066 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 4 (n=77, 69, 67) | 0.433 scores on a scale | Standard Error 0.055 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 6/ET (n=78, 66, 71) | 0.401 scores on a scale | Standard Error 0.053 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 72 hours (n=81, 77, 73) | 0.822 scores on a scale | Standard Error 0.083 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 24 hours (n=72, 69, 69) | 0.836 scores on a scale | Standard Error 0.086 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 2 (n=87, 78, 79) | 0.533 scores on a scale | Standard Error 0.067 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 48 hours (n=83, 86, 77) | 0.918 scores on a scale | Standard Error 0.07 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 6/ET (n=78, 66, 71) | 0.274 scores on a scale | Standard Error 0.053 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 120 hours (n=19, 17, 23) | 0.574 scores on a scale | Standard Error 0.113 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | 96 hours (n=49, 53, 54) | 0.703 scores on a scale | Standard Error 0.09 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Week 4 (n=77, 69, 67) | 0.354 scores on a scale | Standard Error 0.058 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score | Discharge (n=86, 85, 82) | 0.697 scores on a scale | Standard Error 0.069 |
Comparison: 24 hoursp-value: 0.107895% CI: [-0.367, 0.036]ANOVA
Comparison: 24 hoursp-value: 0.640695% CI: [-0.252, 0.155]ANOVA
Comparison: 48 hoursp-value: 0.240495% CI: [-0.289, 0.073]ANOVA
Comparison: 48 hoursp-value: 0.100595% CI: [-0.327, 0.029]ANOVA
Comparison: 72 hoursp-value: 0.210995% CI: [-0.349, 0.078]ANOVA
Comparison: 72 hoursp-value: 0.239995% CI: [-0.342, 0.086]ANOVA
Comparison: 96 hoursp-value: 0.227295% CI: [-0.346, 0.083]ANOVA
Comparison: 96 hoursp-value: 0.441795% CI: [-0.285, 0.125]ANOVA
Comparison: 120 hoursp-value: 0.950295% CI: [-0.299, 0.281]ANOVA
Comparison: 120 hoursp-value: 0.35595% CI: [-0.426, 0.156]ANOVA
Comparison: Dischargep-value: 0.188895% CI: [-0.304, 0.06]ANOVA
Comparison: Dischargep-value: 0.377495% CI: [-0.262, 0.1]ANOVA
Comparison: Week 2p-value: 0.945295% CI: [-0.178, 0.166]ANOVA
Comparison: Week 2p-value: 0.766395% CI: [-0.201, 0.148]ANOVA
Comparison: Week 4p-value: 0.577795% CI: [-0.104, 0.186]ANOVA
Comparison: Week 4p-value: 0.291695% CI: [-0.069, 0.227]ANOVA
Comparison: Week 6/ETp-value: 0.838995% CI: [-0.15, 0.122]ANOVA
Comparison: Week 6/ETp-value: 0.073495% CI: [-0.012, 0.266]ANOVA
Secondary
The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score
The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse).
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 96 hours (n=49, 53, 54) | 0.567 scores on a scale | Standard Error 0.082 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 6/ET (n=78, 66, 71) | 0.230 scores on a scale | Standard Error 0.041 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Discharge (n=86, 85, 82) | 0.530 scores on a scale | Standard Error 0.055 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 120 hours (n=19, 17, 23) | 0.453 scores on a scale | Standard Error 0.084 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 24 hours (n=72, 69, 69) | 0.669 scores on a scale | Standard Error 0.067 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 4 (n=77, 69, 67) | 0.354 scores on a scale | Standard Error 0.044 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 72 hours (n=81, 77, 73) | 0.630 scores on a scale | Standard Error 0.063 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 48 hours (n=83, 86, 77) | 0.743 scores on a scale | Standard Error 0.056 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 2 (n=87, 78, 79) | 0.482 scores on a scale | Standard Error 0.052 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 120 hours (n=19, 17, 23) | 0.393 scores on a scale | Standard Error 0.086 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 24 hours (n=72, 69, 69) | 0.727 scores on a scale | Standard Error 0.069 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 48 hours (n=83, 86, 77) | 0.722 scores on a scale | Standard Error 0.055 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 72 hours (n=81, 77, 73) | 0.637 scores on a scale | Standard Error 0.065 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 96 hours (n=49, 53, 54) | 0.593 scores on a scale | Standard Error 0.079 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Discharge (n=86, 85, 82) | 0.575 scores on a scale | Standard Error 0.055 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 2 (n=87, 78, 79) | 0.467 scores on a scale | Standard Error 0.055 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 4 (n=77, 69, 67) | 0.384 scores on a scale | Standard Error 0.046 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 6/ET (n=78, 66, 71) | 0.355 scores on a scale | Standard Error 0.045 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 72 hours (n=81, 77, 73) | 0.703 scores on a scale | Standard Error 0.067 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 24 hours (n=72, 69, 69) | 0.778 scores on a scale | Standard Error 0.071 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 2 (n=87, 78, 79) | 0.469 scores on a scale | Standard Error 0.056 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 48 hours (n=83, 86, 77) | 0.838 scores on a scale | Standard Error 0.059 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 6/ET (n=78, 66, 71) | 0.229 scores on a scale | Standard Error 0.045 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 120 hours (n=19, 17, 23) | 0.471 scores on a scale | Standard Error 0.085 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | 96 hours (n=49, 53, 54) | 0.637 scores on a scale | Standard Error 0.077 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Week 4 (n=77, 69, 67) | 0.329 scores on a scale | Standard Error 0.048 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score | Discharge (n=86, 85, 82) | 0.615 scores on a scale | Standard Error 0.056 |
Comparison: 24 hoursp-value: 0.194995% CI: [-0.276, 0.057]ANOVA
Comparison: 24 hoursp-value: 0.543195% CI: [-0.22, 0.116]ANOVA
Comparison: 48 hoursp-value: 0.216495% CI: [-0.247, 0.056]ANOVA
Comparison: 48 hoursp-value: 0.125195% CI: [-0.266, 0.033]ANOVA
Comparison: 72 hoursp-value: 0.407995% CI: [-0.247, 0.101]ANOVA
Comparison: 72 hoursp-value: 0.456295% CI: [-0.24, 0.108]ANOVA
Comparison: 96 hoursp-value: 0.452695% CI: [-0.254, 0.114]ANOVA
Comparison: 96 hoursp-value: 0.618695% CI: [-0.221, 0.132]ANOVA
Comparison: 120 hoursp-value: 0.871295% CI: [-0.237, 0.202]ANOVA
Comparison: 120 hoursp-value: 0.478495% CI: [-0.3, 0.143]ANOVA
Comparison: Dischargep-value: 0.263595% CI: [-0.232, 0.064]ANOVA
Comparison: Dischargep-value: 0.600995% CI: [-0.187, 0.108]ANOVA
Comparison: Week 2p-value: 0.855995% CI: [-0.13, 0.156]ANOVA
Comparison: Week 2p-value: 0.984195% CI: [-0.147, 0.144]ANOVA
Comparison: Week 4p-value: 0.677195% CI: [-0.095, 0.146]ANOVA
Comparison: Week 4p-value: 0.371795% CI: [-0.067, 0.178]ANOVA
Comparison: Week 6/ETp-value: 0.986395% CI: [-0.114, 0.116]ANOVA
Comparison: Week 6/ETp-value: 0.035595% CI: [0.009, 0.243]ANOVA
Secondary
The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score
The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
Population: MITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 96 hours (n=49, 53, 54) | 0.509 scores on a scale | Standard Error 0.07 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 6/ET (n=78, 66, 71) | 0.182 scores on a scale | Standard Error 0.034 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Discharge (n=86, 85, 82) | 0.451 scores on a scale | Standard Error 0.048 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 120 hours (n=19, 17, 23) | 0.366 scores on a scale | Standard Error 0.066 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 24 hours (n=72, 69, 69) | 0.579 scores on a scale | Standard Error 0.059 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 4 (n=77, 69, 67) | 0.269 scores on a scale | Standard Error 0.034 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 72 hours (n=81, 77, 73) | 0.539 scores on a scale | Standard Error 0.054 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 48 hours (n=83, 86, 77) | 0.642 scores on a scale | Standard Error 0.051 |
| Pregabalin (150 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 2 (n=87, 78, 79) | 0.390 scores on a scale | Standard Error 0.043 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 120 hours (n=19, 17, 23) | 0.334 scores on a scale | Standard Error 0.067 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 24 hours (n=72, 69, 69) | 0.590 scores on a scale | Standard Error 0.061 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 48 hours (n=83, 86, 77) | 0.624 scores on a scale | Standard Error 0.05 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 72 hours (n=81, 77, 73) | 0.534 scores on a scale | Standard Error 0.055 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 96 hours (n=49, 53, 54) | 0.502 scores on a scale | Standard Error 0.067 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Discharge (n=86, 85, 82) | 0.495 scores on a scale | Standard Error 0.048 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 2 (n=87, 78, 79) | 0.375 scores on a scale | Standard Error 0.045 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 4 (n=77, 69, 67) | 0.308 scores on a scale | Standard Error 0.036 |
| Pregabalin (300 mg) | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 6/ET (n=78, 66, 71) | 0.282 scores on a scale | Standard Error 0.037 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 72 hours (n=81, 77, 73) | 0.562 scores on a scale | Standard Error 0.057 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 24 hours (n=72, 69, 69) | 0.621 scores on a scale | Standard Error 0.062 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 2 (n=87, 78, 79) | 0.364 scores on a scale | Standard Error 0.045 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 48 hours (n=83, 86, 77) | 0.695 scores on a scale | Standard Error 0.053 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 6/ET (n=78, 66, 71) | 0.175 scores on a scale | Standard Error 0.037 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 120 hours (n=19, 17, 23) | 0.391 scores on a scale | Standard Error 0.066 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | 96 hours (n=49, 53, 54) | 0.535 scores on a scale | Standard Error 0.066 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Week 4 (n=77, 69, 67) | 0.247 scores on a scale | Standard Error 0.037 |
| Placebo | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score | Discharge (n=86, 85, 82) | 0.488 scores on a scale | Standard Error 0.049 |
Comparison: 24 hoursp-value: 0.579195% CI: [-0.187, 0.105]ANOVA
Comparison: 24 hoursp-value: 0.682995% CI: [-0.178, 0.117]ANOVA
Comparison: 48 hoursp-value: 0.451695% CI: [-0.19, 0.085]ANOVA
Comparison: 48 hoursp-value: 0.301495% CI: [-0.207, 0.064]ANOVA
Comparison: 72 hoursp-value: 0.762895% CI: [-0.171, 0.125]ANOVA
Comparison: 72 hoursp-value: 0.71195% CI: [-0.176, 0.12]ANOVA
Comparison: 96 hoursp-value: 0.738295% CI: [-0.183, 0.13]ANOVA
Comparison: 96 hoursp-value: 0.658695% CI: [-0.183, 0.116]ANOVA
Comparison: 120 hoursp-value: 0.769195% CI: [-0.195, 0.145]ANOVA
Comparison: 120 hoursp-value: 0.50795% CI: [-0.229, 0.115]ANOVA
Comparison: Dischargep-value: 0.580295% CI: [-0.166, 0.093]ANOVA
Comparison: Dischargep-value: 0.91995% CI: [-0.122, 0.136]ANOVA
Comparison: Week 2p-value: 0.655995% CI: [-0.09, 0.143]ANOVA
Comparison: Week 2p-value: 0.855295% CI: [-0.108, 0.13]ANOVA
Comparison: Week 4p-value: 0.636495% CI: [-0.072, 0.117]ANOVA
Comparison: Week 4p-value: 0.212795% CI: [-0.035, 0.157]ANOVA
Comparison: Week 6/ETp-value: 0.874695% CI: [-0.086, 0.101]ANOVA
Comparison: Week 6/ETp-value: 0.028695% CI: [0.011, 0.202]ANOVA
Secondary
Timed Up-and-Go (TUG)
TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again.
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET
Population: MITT. There were not enough subjects with data at 120 (Pregabalin 300 mg only), 144, 168, and 192 hours to calculate least squares mean values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | Week 4 (n=73, 65, 63) | 18.072 seconds | Standard Error 1.537 |
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | 72 hours (n=46, 46, 46) | 66.228 seconds | Standard Error 8.429 |
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | 120 hours (n=5, 2, 5) | 52.591 seconds | Standard Error 5.102 |
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | Week 2 (n=78, 71, 72) | 22.322 seconds | Standard Error 2.087 |
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | 96 hours (n=14, 14, 22) | 110.780 seconds | Standard Error 45.437 |
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | Week 6/ET (n=75, 60, 63) | 12.694 seconds | Standard Error 1.226 |
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | 48 hours (n=69, 70, 64) | 80.027 seconds | Standard Error 8.601 |
| Pregabalin (150 mg) | Timed Up-and-Go (TUG) | 24 hours (n=45, 47, 46) | 76.153 seconds | Standard Error 10.449 |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | Week 6/ET (n=75, 60, 63) | 15.140 seconds | Standard Error 1.437 |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | 120 hours (n=5, 2, 5) | NA seconds | — |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | 24 hours (n=45, 47, 46) | 79.973 seconds | Standard Error 8.719 |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | 48 hours (n=69, 70, 64) | 79.548 seconds | Standard Error 8.111 |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | 72 hours (n=46, 46, 46) | 68.373 seconds | Standard Error 8.561 |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | 96 hours (n=14, 14, 22) | 43.021 seconds | Standard Error 36.751 |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | Week 2 (n=78, 71, 72) | 21.332 seconds | Standard Error 2.091 |
| Pregabalin (300 mg) | Timed Up-and-Go (TUG) | Week 4 (n=73, 65, 63) | 18.145 seconds | Standard Error 1.527 |
| Placebo | Timed Up-and-Go (TUG) | 72 hours (n=46, 46, 46) | 80.142 seconds | Standard Error 9.276 |
| Placebo | Timed Up-and-Go (TUG) | 24 hours (n=45, 47, 46) | 82.964 seconds | Standard Error 10.174 |
| Placebo | Timed Up-and-Go (TUG) | Week 2 (n=78, 71, 72) | 21.678 seconds | Standard Error 2.113 |
| Placebo | Timed Up-and-Go (TUG) | 48 hours (n=69, 70, 64) | 86.842 seconds | Standard Error 8.927 |
| Placebo | Timed Up-and-Go (TUG) | Week 6/ET (n=75, 60, 63) | 13.813 seconds | Standard Error 1.408 |
| Placebo | Timed Up-and-Go (TUG) | Week 4 (n=73, 65, 63) | 16.535 seconds | Standard Error 1.563 |
| Placebo | Timed Up-and-Go (TUG) | 96 hours (n=14, 14, 22) | 70.271 seconds | Standard Error 37.742 |
| Placebo | Timed Up-and-Go (TUG) | 120 hours (n=5, 2, 5) | 34.078 seconds | Standard Error 4.7 |
Comparison: 24 hoursp-value: 0.573695% CI: [-30.792, 17.169]ANOVA
Comparison: 24 hoursp-value: 0.800395% CI: [-26.438, 20.455]ANOVA
Comparison: 48 hoursp-value: 0.512595% CI: [-27.369, 13.74]ANOVA
Comparison: 48 hoursp-value: 0.477395% CI: [-27.563, 12.976]ANOVA
Comparison: 72 hoursp-value: 0.214295% CI: [-36.055, 8.226]ANOVA
Comparison: 72 hoursp-value: 0.298995% CI: [-34.197, 10.659]ANOVA
Comparison: 96 hoursp-value: 0.382995% CI: [-53.429, 134.449]ANOVA
Comparison: 96 hoursp-value: 0.553195% CI: [-120.59, 66.092]ANOVA
Comparison: 120 hoursp-value: 0.273895% CI: [-89.376, 126.402]ANOVA
Comparison: Week 2p-value: 0.798795% CI: [-4.343, 5.63]ANOVA
Comparison: Week 2p-value: 0.887595% CI: [-5.177, 4.485]ANOVA
Comparison: Week 4p-value: 0.431995% CI: [-2.324, 5.398]ANOVA
Comparison: Week 4p-value: 0.40795% CI: [-2.223, 5.443]ANOVA
Comparison: Week 6/ETp-value: 0.496895% CI: [-4.371, 2.133]ANOVA
Comparison: Week 6/ETp-value: 0.42795% CI: [-1.972, 4.626]ANOVA
Secondary
Time From End of Surgery to Actual Discharge
The analysis was performed by Kaplan-Meier method with log-rank test.
Time frame: time from end of surgery up to 192 hours post surgery
Population: MITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin (150 mg) | Time From End of Surgery to Actual Discharge | 75.709 hours | Standard Error 2.798 |
| Pregabalin (300 mg) | Time From End of Surgery to Actual Discharge | 73.906 hours | Standard Error 2.404 |
| Placebo | Time From End of Surgery to Actual Discharge | 78.451 hours | Standard Error 2.715 |
p-value: 0.4024Log Rank
p-value: 0.191Log Rank
Secondary
Time From End of Surgery to Meet Hospital Discharge Criteria
The analysis was performed by Kaplan-Meier method with log-rank test.
Time frame: time from end of surgery up to 192 hours post surgery
Population: MITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin (150 mg) | Time From End of Surgery to Meet Hospital Discharge Criteria | 106.802 hours | Standard Error 6.059 |
| Pregabalin (300 mg) | Time From End of Surgery to Meet Hospital Discharge Criteria | 112.966 hours | Standard Error 7.707 |
| Placebo | Time From End of Surgery to Meet Hospital Discharge Criteria | 95.531 hours | Standard Error 3.385 |
p-value: 0.4365Log Rank
p-value: 0.4023Log Rank
Secondary
Total Clinically Meaningful Event (CME) Score
CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9.
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET
Population: MITT.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | 96 hours (n=49, 53, 54) | 0.440 scores on a scale | Standard Error 0.173 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | Week 6/ET (n=78, 66, 71) | 0.059 scores on a scale | Standard Error 0.062 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | Discharge (n=86, 85, 82) | 0.429 scores on a scale | Standard Error 0.113 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | 120 hours (n=19, 17, 23) | 0.178 scores on a scale | Standard Error 0.089 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | 24 hours (n=72, 69, 69) | 0.822 scores on a scale | Standard Error 0.161 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | Week 4 (n=77, 69, 67) | 0.116 scores on a scale | Standard Error 0.059 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | 72 hours (n=81, 77, 73) | 0.647 scores on a scale | Standard Error 0.134 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | 48 hours (n=83, 86, 87) | 0.814 scores on a scale | Standard Error 0.141 |
| Pregabalin (150 mg) | Total Clinically Meaningful Event (CME) Score | Week 2 (n=87, 78, 79) | 0.328 scores on a scale | Standard Error 0.093 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | 120 hours (n=19, 17, 23) | 0.350 scores on a scale | Standard Error 0.091 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | 24 hours (n=72, 69, 69) | 0.817 scores on a scale | Standard Error 0.166 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | 48 hours (n=83, 86, 87) | 0.834 scores on a scale | Standard Error 0.138 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | 72 hours (n=81, 77, 73) | 0.570 scores on a scale | Standard Error 0.138 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | 96 hours (n=49, 53, 54) | 0.489 scores on a scale | Standard Error 0.164 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | Discharge (n=86, 85, 82) | 0.502 scores on a scale | Standard Error 0.114 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | Week 2 (n=87, 78, 79) | 0.311 scores on a scale | Standard Error 0.097 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | Week 4 (n=77, 69, 67) | 0.236 scores on a scale | Standard Error 0.062 |
| Pregabalin (300 mg) | Total Clinically Meaningful Event (CME) Score | Week 6/ET (n=78, 66, 71) | 0.260 scores on a scale | Standard Error 0.068 |
| Placebo | Total Clinically Meaningful Event (CME) Score | 72 hours (n=81, 77, 73) | 0.613 scores on a scale | Standard Error 0.144 |
| Placebo | Total Clinically Meaningful Event (CME) Score | 24 hours (n=72, 69, 69) | 0.772 scores on a scale | Standard Error 0.171 |
| Placebo | Total Clinically Meaningful Event (CME) Score | Week 2 (n=87, 78, 79) | 0.171 scores on a scale | Standard Error 0.099 |
| Placebo | Total Clinically Meaningful Event (CME) Score | 48 hours (n=83, 86, 87) | 0.789 scores on a scale | Standard Error 0.146 |
| Placebo | Total Clinically Meaningful Event (CME) Score | Week 6/ET (n=78, 66, 71) | 0.051 scores on a scale | Standard Error 0.067 |
| Placebo | Total Clinically Meaningful Event (CME) Score | 120 hours (n=19, 17, 23) | 0.246 scores on a scale | Standard Error 0.09 |
| Placebo | Total Clinically Meaningful Event (CME) Score | 96 hours (n=49, 53, 54) | 0.284 scores on a scale | Standard Error 0.162 |
| Placebo | Total Clinically Meaningful Event (CME) Score | Week 4 (n=77, 69, 67) | 0.032 scores on a scale | Standard Error 0.064 |
| Placebo | Total Clinically Meaningful Event (CME) Score | Discharge (n=86, 85, 82) | 0.352 scores on a scale | Standard Error 0.117 |
Comparison: 24 hoursp-value: 0.807195% CI: [-0.35, 0.449]ANOVA
Comparison: 24 hoursp-value: 0.828295% CI: [-0.359, 0.447]ANOVA
Comparison: 48 hoursp-value: 0.897295% CI: [-0.353, 0.403]ANOVA
Comparison: 48 hoursp-value: 0.815995% CI: [-0.329, 0.418]ANOVA
Comparison: 72 hoursp-value: 0.857795% CI: [-0.337, 0.405]ANOVA
Comparison: 72 hoursp-value: 0.815895% CI: [-0.415, 0.327]ANOVA
Comparison: 96 hoursp-value: 0.424395% CI: [-0.229, 0.541]ANOVA
Comparison: 96 hoursp-value: 0.274295% CI: [-0.164, 0.574]ANOVA
Comparison: 120 hoursp-value: 0.556995% CI: [-0.302, 0.165]ANOVA
Comparison: 120 hoursp-value: 0.376295% CI: [-0.13, 0.336]ANOVA
Comparison: Dischargep-value: 0.620395% CI: [-0.229, 0.383]ANOVA
Comparison: Dischargep-value: 0.334395% CI: [-0.155, 0.455]ANOVA
Comparison: Week 2p-value: 0.221395% CI: [-0.096, 0.41]ANOVA
Comparison: Week 2p-value: 0.286395% CI: [-0.118, 0.399]ANOVA
Comparison: Week 4p-value: 0.30595% CI: [-0.077, 0.245]ANOVA
Comparison: Week 4p-value: 0.015595% CI: [0.039, 0.368]ANOVA
Comparison: Week 6/ETp-value: 0.924395% CI: [-0.164, 0.181]ANOVA
Comparison: Week 6/ETp-value: 0.020195% CI: [0.033, 0.386]ANOVA