Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00468845

Enrollment

501

Registered

2007-05-03

Start date

2007-06-30

Completion date

2010-10-31

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

pain after hysterectomy, amount of opioids used

Brief summary

To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.

Interventions

DRUGpregabalin (Lyrica)

150 mg/day double blind (divided doses)

DRUGmatched placebo

matched placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 70 Years

Healthy volunteers

Inclusion criteria

* The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing. * The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery. * The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.

Exclusion criteria

* Subjects having vaginal hysterectomy (whether laparoscopically assisted or not) * Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy * The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control * Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit. * The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking \<325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).

Design outcomes

Primary

Measure	Time frame	Description
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)	Day 2 (24 hours post surgery [PS])	Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Secondary

Measure	Time frame	Description
Quality of Life Using EuroQol (EQ-5D) Health State Profile	Discharge (day 3 up to day 7 PS) and day 28 PS	Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, confined to bed). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata.
Participant Satisfaction With Study Medication - Day 28 PS	Day 28 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Discharge (day 3 up to day 7 PS), Day 28 PS	Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	Discharge (day 3 up to day 7 PS), Day 28 PS	Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Time to Meet Hospital Discharge Criteria	Day 1 up to Day 7 PS	Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.
Time to Actual Discharge	Day 1 up to Day 7 PS	Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.
Incidence of Chronic Post-operative Pain	3 and 6 Months PS	Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.
Total Clinically Meaningful Event (CME) Score	Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS	Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Average Daily Pain	Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS	Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Current Pain - Pain With Movement Caused by Sitting	Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS	Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	Day 1, up to 7 days PS, 2 and 4 weeks PS	Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting	48 +/- 4 hours PS	Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test	48 +/- 4 hours PS	Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Current Pain at Rest	8, 16, 24, 32, 40, 48 hours PS	Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay	48 +/- 4 hours PS	Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Total Cumulative Dose of Opioids Following Surgery	24, 48 Hours PS, Discharge (day 3 up to day 7 PS)	Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Integrated Analgesic Score	0-24, 24-48, 48-72 hours PS	The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Non-opioid Rescue Medication - Paracetamol	24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,	The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.
Anxiety Before and After Surgery	Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)	Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata
Non-opioid Rescue Medication - Ibuprofen	24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS	The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.
Percent Change From Baseline in Peak Expiratory Flow	Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)	Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Timed Up-and-Go (TUG)	Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)	Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Worst Daily Pain	Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS	Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.
Sleep Interference	Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS	Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS	m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS	m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Participant Satisfaction With Study Medication - Surgery Day	Day 1	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Day 1 PS	Day 1 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Day 2 PS	Day 2 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Day 3 PS	Day 3 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Day 4 PS	Day 4 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Day 5 PS	Day 5 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Discharge	Discharge (day 3 up to day 7 PS)	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Day 7 PS	Day 7 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
Participant Satisfaction With Study Medication - Day 14 PS	Day 14 PS	Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Other

Measure	Time frame	Description
Percentage of Participants With Wound Healing Complications - Day 14 PS	Day 14 PS	Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
Percentage of Participants With Wound Healing Complications - Day 28 PS	Day 28 PS	Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
Percentage of Participants With Wound Healing Complications - End of Treatment	Day 1 up to Day 28 PS	Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
Incision Length Correlated With Worst Pain	Day 1	Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.
Neuropathic Pain Symptom Inventory (NPSI)	Discharge (day 3 up to day 7 PS)	Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Percentage of Participants With Wound Healing Complications - Discharge	Discharge (day 3 up to day 7 PS)	Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
Percentage of Participants With Wound Healing Complications - Day 7 PS	Day 7 PS	Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.

Countries

Canada, Czechia, Hong Kong, South Africa, Spain, Sweden, Thailand, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
Pregabalin 150mg Pregabalin 75 mg twice a day (150 mg/day total)	162
Pregabalin 300 mg Pregabalin 150 mg twice a day (300 mg/day total)	170
Placebo Matching placebo capsule	169
Total	501

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	9	14	11
Overall Study	Lost to Follow-up	2	1	2
Overall Study	No longer willing to participate	5	6	10
Overall Study	Other	4	9	5
Overall Study	Randomized, not treated	1	4	2

Baseline characteristics

Characteristic	Pregabalin 150mg	Pregabalin 300 mg	Placebo	Total
Age, Customized 25-44 years	77 participants	76 participants	88 participants	241 participants
Age, Customized 45-70 years	84 participants	90 participants	79 participants	253 participants
Age, Customized Unspecified	1 participants	4 participants	2 participants	7 participants
Sex: Female, Male Female	162 Participants	170 Participants	169 Participants	501 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 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	125 / 161	128 / 166	124 / 167
serious Total, serious adverse events	9 / 161	11 / 166	15 / 167

Outcome results

Primary

Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)

Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Day 2 (24 hours post surgery [PS])

Population: Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)	7.1 Units on a scale	Standard Error 0.18
Pregabalin 300 mg	Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)	7.2 Units on a scale	Standard Error 0.18
Placebo	Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)	7.4 Units on a scale	Standard Error 0.18

p-value: 0.1378ANOVA

p-value: 0.471ANOVA

Secondary

Anxiety Before and After Surgery

Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata

Time frame: Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Anxiety Before and After Surgery	Surgery Day (prior to first dose)(n=149, 144, 151)	31.9 Units on a scale	Standard Error 2.38
Pregabalin 150mg	Anxiety Before and After Surgery	Surgery Day (1 hour after dosing)(n=138, 139, 146)	29.5 Units on a scale	Standard Error 2.39
Pregabalin 150mg	Anxiety Before and After Surgery	Day 1 PS (n=150, 149, 154)	15.6 Units on a scale	Standard Error 1.75
Pregabalin 150mg	Anxiety Before and After Surgery	Day 2 PS (n=112, 120, 118)	12.6 Units on a scale	Standard Error 2.05
Pregabalin 150mg	Anxiety Before and After Surgery	Day 3 PS (n=44, 40, 35)	17.2 Units on a scale	Standard Error 3.17
Pregabalin 150mg	Anxiety Before and After Surgery	Day 4 PS (n=17, 20, 15)	9.0 Units on a scale	Standard Error 3.22
Pregabalin 150mg	Anxiety Before and After Surgery	Day 5 PS (n=7, 13, 7)	11.6 Units on a scale	Standard Error 8.31
Pregabalin 150mg	Anxiety Before and After Surgery	Discharge (n=143, 144, 148)	10.2 Units on a scale	Standard Error 1.5
Pregabalin 300 mg	Anxiety Before and After Surgery	Day 1 PS (n=150, 149, 154)	16.1 Units on a scale	Standard Error 1.78
Pregabalin 300 mg	Anxiety Before and After Surgery	Day 5 PS (n=7, 13, 7)	4.5 Units on a scale	Standard Error 5.39
Pregabalin 300 mg	Anxiety Before and After Surgery	Day 2 PS (n=112, 120, 118)	13.4 Units on a scale	Standard Error 1.98
Pregabalin 300 mg	Anxiety Before and After Surgery	Day 3 PS (n=44, 40, 35)	11.2 Units on a scale	Standard Error 2.93
Pregabalin 300 mg	Anxiety Before and After Surgery	Day 4 PS (n=17, 20, 15)	4.2 Units on a scale	Standard Error 2.72
Pregabalin 300 mg	Anxiety Before and After Surgery	Surgery Day (prior to first dose)(n=149, 144, 151)	28.4 Units on a scale	Standard Error 2.45
Pregabalin 300 mg	Anxiety Before and After Surgery	Surgery Day (1 hour after dosing)(n=138, 139, 146)	29.7 Units on a scale	Standard Error 2.39
Pregabalin 300 mg	Anxiety Before and After Surgery	Discharge (n=143, 144, 148)	8.3 Units on a scale	Standard Error 1.5
Placebo	Anxiety Before and After Surgery	Day 1 PS (n=150, 149, 154)	18.6 Units on a scale	Standard Error 1.77
Placebo	Anxiety Before and After Surgery	Surgery Day (1 hour after dosing)(n=138, 139, 146)	30.9 Units on a scale	Standard Error 2.38
Placebo	Anxiety Before and After Surgery	Surgery Day (prior to first dose)(n=149, 144, 151)	33.3 Units on a scale	Standard Error 2.4
Placebo	Anxiety Before and After Surgery	Day 2 PS (n=112, 120, 118)	13.8 Units on a scale	Standard Error 2.03
Placebo	Anxiety Before and After Surgery	Day 5 PS (n=7, 13, 7)	15.1 Units on a scale	Standard Error 8.46
Placebo	Anxiety Before and After Surgery	Day 4 PS (n=17, 20, 15)	9.3 Units on a scale	Standard Error 3.51
Placebo	Anxiety Before and After Surgery	Day 3 PS (n=44, 40, 35)	13.9 Units on a scale	Standard Error 3.2
Placebo	Anxiety Before and After Surgery	Discharge (n=143, 144, 148)	8.8 Units on a scale	Standard Error 1.5

Comparison: Surgery day (prior to first dose)p-value: 0.6613ANOVA

Comparison: Surgery day (prior to first dose)p-value: 0.1311ANOVA

Comparison: Surgery day (1 hour after dosing)p-value: 0.6574ANOVA

Comparison: Surgery day (1 hour after dosing)p-value: 0.6949ANOVA

Comparison: Day 1 PSp-value: 0.2008ANOVA

Comparison: Day 1 PSp-value: 0.3022ANOVA

Comparison: Day 2 PSp-value: 0.6382ANOVA

Comparison: Day 2 PSp-value: 0.8624ANOVA

Comparison: Day 3 PSp-value: 0.3858ANOVA

Comparison: Day 3 PSp-value: 0.4814ANOVA

Comparison: Day 4 PSp-value: 0.952ANOVA

Comparison: Day 4 PSp-value: 0.2315ANOVA

Comparison: Day 5 PSp-value: 0.7061ANOVA

Comparison: Day 5 PSp-value: 0.2908ANOVA

Comparison: Dischargep-value: 0.4782ANOVA

Comparison: Dischargep-value: 0.813ANOVA

Secondary

Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay

Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: 48 +/- 4 hours PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay	3.62 Units on a scale	Standard Error 0.143
Pregabalin 300 mg	Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay	3.58 Units on a scale	Standard Error 0.147
Placebo	Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay	3.76 Units on a scale	Standard Error 0.144

p-value: 0.4388ANOVA

p-value: 0.3364ANOVA

Secondary

Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test

Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: 48 +/- 4 hours PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test	4.45 Units on a scale	Standard Error 0.167
Pregabalin 300 mg	Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test	4.64 Units on a scale	Standard Error 0.174
Placebo	Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test	4.61 Units on a scale	Standard Error 0.173

p-value: 0.4801ANOVA

p-value: 0.8832ANOVA

Secondary

Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting

Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: 48 +/- 4 hours PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting	4.87 Units on a scale	Standard Error 0.155
Pregabalin 300 mg	Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting	5.01 Units on a scale	Standard Error 0.161
Placebo	Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting	4.87 Units on a scale	Standard Error 0.157

p-value: 0.9676ANOVA

p-value: 0.4944ANOVA

Secondary

Average Daily Pain

Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Average Daily Pain	Day 5 PS (n=133, 117, 133)	2.5 Units on a scale	Standard Error 0.18
Pregabalin 150mg	Average Daily Pain	4th Week PS (Average) (n=87, 87, 82)	1.2 Units on a scale	Standard Error 0.18
Pregabalin 150mg	Average Daily Pain	Day 7 PS (n=132, 130, 135)	2.1 Units on a scale	Standard Error 0.17
Pregabalin 150mg	Average Daily Pain	Day 6 PS (n=133, 125, 138)	2.3 Units on a scale	Standard Error 0.18
Pregabalin 150mg	Average Daily Pain	Day 2 PS (n=29, 21, 25)	3.9 Units on a scale	Standard Error 0.48
Pregabalin 150mg	Average Daily Pain	3rd Week PS (Average) (n=114, 110, 114)	1.3 Units on a scale	Standard Error 0.15
Pregabalin 150mg	Average Daily Pain	Day 4 PS (n=126, 114, 125)	2.7 Units on a scale	Standard Error 0.19
Pregabalin 150mg	Average Daily Pain	Day 3 PS (n=97, 94, 98)	3.0 Units on a scale	Standard Error 0.22
Pregabalin 150mg	Average Daily Pain	2nd Week PS (Average) (n=134, 131, 139)	1.7 Units on a scale	Standard Error 0.14
Pregabalin 300 mg	Average Daily Pain	Day 6 PS (n=133, 125, 138)	2.5 Units on a scale	Standard Error 0.19
Pregabalin 300 mg	Average Daily Pain	Day 2 PS (n=29, 21, 25)	4.3 Units on a scale	Standard Error 0.55
Pregabalin 300 mg	Average Daily Pain	Day 3 PS (n=97, 94, 98)	3.2 Units on a scale	Standard Error 0.23
Pregabalin 300 mg	Average Daily Pain	Day 4 PS (n=126, 114, 125)	2.9 Units on a scale	Standard Error 0.21
Pregabalin 300 mg	Average Daily Pain	Day 5 PS (n=133, 117, 133)	2.6 Units on a scale	Standard Error 0.2
Pregabalin 300 mg	Average Daily Pain	Day 7 PS (n=132, 130, 135)	2.3 Units on a scale	Standard Error 0.17
Pregabalin 300 mg	Average Daily Pain	2nd Week PS (Average) (n=134, 131, 139)	2.0 Units on a scale	Standard Error 0.14
Pregabalin 300 mg	Average Daily Pain	3rd Week PS (Average) (n=114, 110, 114)	1.7 Units on a scale	Standard Error 0.15
Pregabalin 300 mg	Average Daily Pain	4th Week PS (Average) (n=87, 87, 82)	1.6 Units on a scale	Standard Error 0.19
Placebo	Average Daily Pain	Day 4 PS (n=126, 114, 125)	2.8 Units on a scale	Standard Error 0.2
Placebo	Average Daily Pain	Day 2 PS (n=29, 21, 25)	3.1 Units on a scale	Standard Error 0.59
Placebo	Average Daily Pain	2nd Week PS (Average) (n=134, 131, 139)	1.7 Units on a scale	Standard Error 0.14
Placebo	Average Daily Pain	Day 3 PS (n=97, 94, 98)	2.8 Units on a scale	Standard Error 0.23
Placebo	Average Daily Pain	4th Week PS (Average) (n=87, 87, 82)	1.2 Units on a scale	Standard Error 0.2
Placebo	Average Daily Pain	Day 6 PS (n=133, 125, 138)	2.4 Units on a scale	Standard Error 0.18
Placebo	Average Daily Pain	Day 5 PS (n=133, 117, 133)	2.6 Units on a scale	Standard Error 0.19
Placebo	Average Daily Pain	3rd Week PS (Average) (n=114, 110, 114)	1.3 Units on a scale	Standard Error 0.16
Placebo	Average Daily Pain	Day 7 PS (n=132, 130, 135)	2.2 Units on a scale	Standard Error 0.17

Comparison: Day 2 PSp-value: 0.2201ANOVA

Comparison: Day 2 PSp-value: 0.0606ANOVA

Comparison: Day 3 PSp-value: 0.5303ANOVA

Comparison: Day 3 PSp-value: 0.2227ANOVA

Comparison: Day 4 PSp-value: 0.8237ANOVA

Comparison: Day 4 PSp-value: 0.7476ANOVA

Comparison: Day 5 PSp-value: 0.6882ANOVA

Comparison: Day 5 PSp-value: 0.9689ANOVA

Comparison: Day 6 PSp-value: 0.501ANOVA

Comparison: Day 6 PSp-value: 0.9143ANOVA

Comparison: Day 7 PSp-value: 0.7381ANOVA

Comparison: Day 7 PSp-value: 0.5336ANOVA

Comparison: 2nd Week PS (Average)p-value: 0.6479ANOVA

Comparison: 2nd Week PS (Average)p-value: 0.1133ANOVA

Comparison: 3rd Week PS (Average)p-value: 0.7637ANOVA

Comparison: 3rd Week PS (Average)p-value: 0.1056ANOVA

Comparison: 4th Week PS (Average)p-value: 0.8079ANOVA

Comparison: 4th Week PS (Average)p-value: 0.0917ANOVA

Secondary

Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores

m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 28 (n=140, 141, 142)	0.85 Units on a scale	Standard Error 0.122
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 7 (n=121, 119, 123)	1.96 Units on a scale	Standard Error 0.201
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Baseline (n=149, 147, 154)	0 Units on a scale	Standard Error 0
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Discharge (n=133, 131, 130)	2.57 Units on a scale	Standard Error 0.194
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 14 (n=129, 123, 126)	1.20 Units on a scale	Standard Error 0.148
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 7 (n=121, 119, 123)	2.09 Units on a scale	Standard Error 0.206
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Baseline (n=149, 147, 154)	0 Units on a scale	Standard Error 0
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Discharge (n=133, 131, 130)	2.62 Units on a scale	Standard Error 0.198
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 28 (n=140, 141, 142)	1.01 Units on a scale	Standard Error 0.122
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 14 (n=129, 123, 126)	1.41 Units on a scale	Standard Error 0.152
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 14 (n=129, 123, 126)	1.68 Units on a scale	Standard Error 0.152
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 28 (n=140, 141, 142)	1.07 Units on a scale	Standard Error 0.123
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Baseline (n=149, 147, 154)	0 Units on a scale	Standard Error 0
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Day 7 (n=121, 119, 123)	2.52 Units on a scale	Standard Error 0.198
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	Discharge (n=133, 131, 130)	2.90 Units on a scale	Standard Error 0.2

Comparison: Discharge;p-value: 0.1975ANOVA

Comparison: Discharge;p-value: 0.2784ANOVA

Comparison: Day 7p-value: 0.0271ANOVA

Comparison: Day 7p-value: 0.0881ANOVA

Comparison: Day 14p-value: 0.0159ANOVA

Comparison: Day 14p-value: 0.187ANOVA

Comparison: Day 28p-value: 0.1752ANOVA

Comparison: Day 28p-value: 0.6923ANOVA

Secondary

Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores

m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 14 (n=129, 124, 130)	1.19 Units on a scale	Standard Error 0.137
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 7 (n=122, 121, 125)	2.05 Units on a scale	Standard Error 0.172
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Baseline (n=149, 147, 155)	0 Units on a scale	Standard Error 0
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Discharge (n=140, 141, 138)	2.62 Units on a scale	Standard Error 0.137
Pregabalin 150mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 28 (n=141, 142, 143)	0.79 Units on a scale	Standard Error 0.11
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 7 (n=122, 121, 125)	2.16 Units on a scale	Standard Error 0.177
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Baseline (n=149, 147, 155)	0 Units on a scale	Standard Error 0
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Discharge (n=140, 141, 138)	2.60 Units on a scale	Standard Error 0.137
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 14 (n=129, 124, 130)	1.63 Units on a scale	Standard Error 0.142
Pregabalin 300 mg	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 28 (n=141, 142, 143)	0.98 Units on a scale	Standard Error 0.11
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 28 (n=141, 142, 143)	0.83 Units on a scale	Standard Error 0.11
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 14 (n=129, 124, 130)	1.61 Units on a scale	Standard Error 0.138
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Baseline (n=149, 147, 155)	0 Units on a scale	Standard Error 0
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Day 7 (n=122, 121, 125)	2.20 Units on a scale	Standard Error 0.169
Placebo	Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	Discharge (n=140, 141, 138)	2.53 Units on a scale	Standard Error 0.141

Comparison: Dischargep-value: 0.6295ANOVA

Comparison: Dischargep-value: 0.689ANOVA

Comparison: Day 7p-value: 0.5094ANOVA

Comparison: Day 7p-value: 0.8741ANOVA

Comparison: Day 14p-value: 0.0214ANOVA

Comparison: Day 14p-value: 0.9366ANOVA

Comparison: Day 28p-value: 0.7833ANOVA

Comparison: Day 28p-value: 0.2983ANOVA

Secondary

Current Pain at Rest

Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: 8, 16, 24, 32, 40, 48 hours PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Current Pain at Rest	8 Hours PS (n=123, 125, 126)	5.13 Units on a scale	Standard Error 0.232
Pregabalin 150mg	Current Pain at Rest	16 Hours PS (n=94, 88, 107)	4.06 Units on a scale	Standard Error 0.256
Pregabalin 150mg	Current Pain at Rest	24 Hours PS (n=151, 147, 154)	3.79 Units on a scale	Standard Error 0.179
Pregabalin 150mg	Current Pain at Rest	32 Hours PS (n=127, 127, 136)	3.37 Units on a scale	Standard Error 0.207
Pregabalin 150mg	Current Pain at Rest	40 Hours PS (n=93, 97, 100)	2.97 Units on a scale	Standard Error 0.265
Pregabalin 150mg	Current Pain at Rest	48 Hours PS (n=142, 143, 140)	2.60 Units on a scale	Standard Error 0.173
Pregabalin 300 mg	Current Pain at Rest	48 Hours PS (n=142, 143, 140)	2.26 Units on a scale	Standard Error 0.174
Pregabalin 300 mg	Current Pain at Rest	8 Hours PS (n=123, 125, 126)	5.39 Units on a scale	Standard Error 0.231
Pregabalin 300 mg	Current Pain at Rest	32 Hours PS (n=127, 127, 136)	3.31 Units on a scale	Standard Error 0.212
Pregabalin 300 mg	Current Pain at Rest	40 Hours PS (n=93, 97, 100)	2.71 Units on a scale	Standard Error 0.265
Pregabalin 300 mg	Current Pain at Rest	16 Hours PS (n=94, 88, 107)	4.55 Units on a scale	Standard Error 0.273
Pregabalin 300 mg	Current Pain at Rest	24 Hours PS (n=151, 147, 154)	3.76 Units on a scale	Standard Error 0.184
Placebo	Current Pain at Rest	16 Hours PS (n=94, 88, 107)	4.30 Units on a scale	Standard Error 0.245
Placebo	Current Pain at Rest	24 Hours PS (n=151, 147, 154)	3.93 Units on a scale	Standard Error 0.18
Placebo	Current Pain at Rest	48 Hours PS (n=142, 143, 140)	2.65 Units on a scale	Standard Error 0.179
Placebo	Current Pain at Rest	32 Hours PS (n=127, 127, 136)	3.55 Units on a scale	Standard Error 0.204
Placebo	Current Pain at Rest	8 Hours PS (n=123, 125, 126)	5.47 Units on a scale	Standard Error 0.225
Placebo	Current Pain at Rest	40 Hours PS (n=93, 97, 100)	2.98 Units on a scale	Standard Error 0.263

Comparison: 8 Hours PSp-value: 0.2125ANOVA

Comparison: 8 Hour PSp-value: 0.7602ANOVA

Comparison: 16 Hours PSp-value: 0.4053ANOVA

Comparison: 16 Hours PSp-value: 0.4147ANOVA

Comparison: 24 Hours PSp-value: 0.5556ANOVA

Comparison: 24 Hours PSp-value: 0.482ANOVA

Comparison: 32 Hours PSp-value: 0.5088ANOVA

Comparison: 32 Hours PSp-value: 0.39ANOVA

Comparison: 40 Hours PSp-value: 0.9659ANOVA

Comparison: 40 Hours PSp-value: 0.3968ANOVA

Comparison: 48 Hours PSp-value: 0.8308ANOVA

Comparison: 48 Hours PSp-value: 0.0902ANOVA

Secondary

Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test

Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Day 1, up to 7 days PS, 2 and 4 weeks PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	24 hours PS (n=146, 142, 148)	4.83 Units on a scale	Standard Error 0.202
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	48 hours PS (n=141, 143, 140)	3.22 Units on a scale	Standard Error 0.204
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	72 hours PS (n=83, 90, 74)	2.62 Units on a scale	Standard Error 0.242
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	96 hours PS (n=28, 31, 25)	1.88 Units on a scale	Standard Error 0.465
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	120 hours PS (n=13, 14, 11)	1.97 Units on a scale	Standard Error 0.685
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	144 hours PS (n=2, 5, 3)	3.67 Units on a scale	Standard Error 2.472
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	144 hours PS (n=2, 5, 3)	0.67 Units on a scale	Standard Error 1.453
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	24 hours PS (n=146, 142, 148)	4.92 Units on a scale	Standard Error 0.209
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	96 hours PS (n=28, 31, 25)	3.05 Units on a scale	Standard Error 0.414
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	120 hours PS (n=13, 14, 11)	2.10 Units on a scale	Standard Error 0.609
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	48 hours PS (n=141, 143, 140)	3.47 Units on a scale	Standard Error 0.205
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	72 hours PS (n=83, 90, 74)	2.69 Units on a scale	Standard Error 0.228
Placebo	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	48 hours PS (n=141, 143, 140)	3.46 Units on a scale	Standard Error 0.21
Placebo	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	72 hours PS (n=83, 90, 74)	3.04 Units on a scale	Standard Error 0.263
Placebo	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	144 hours PS (n=2, 5, 3)	1.67 Units on a scale	Standard Error 1.764
Placebo	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	96 hours PS (n=28, 31, 25)	3.28 Units on a scale	Standard Error 0.487
Placebo	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	24 hours PS (n=146, 142, 148)	4.97 Units on a scale	Standard Error 0.207
Placebo	Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	120 hours PS (n=13, 14, 11)	1.45 Units on a scale	Standard Error 0.74

Comparison: 24 hours PSp-value: 0.5997ANOVA

Comparison: 24 hours PSp-value: 0.8582ANOVA

Comparison: 48 hours PSp-value: 0.3704ANOVA

Comparison: 48 hours PSp-value: 0.9747ANOVA

Comparison: 72 hours PSp-value: 0.2033ANOVA

Comparison: 72 hours PSp-value: 0.2752ANOVA

Comparison: 96 hours PSp-value: 0.0183ANOVA

Comparison: 96 hours PSp-value: 0.6906ANOVA

Comparison: 120 hours PSp-value: 0.5446ANOVA

Comparison: 120 hours PSp-value: 0.4852ANOVA

Comparison: 144 hours PSp-value: 0.5879ANOVA

Comparison: 144 hours PSp-value: 0.7699ANOVA

Secondary

Current Pain - Pain With Movement Caused by Sitting

Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	96 Hours PS (n=29, 31, 26)	2.31 Units on a scale	Standard Error 0.425
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	Day 28 (n=138, 138, 142)	0.70 Units on a scale	Standard Error 0.126
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	144 Hours PS (n=2, 5, 5)	1.86 Units on a scale	Standard Error 1.496
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	120 Hours PS (n=14, 15, 12)	2.89 Units on a scale	Standard Error 0.584
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	24 Hours PS (n=147, 141, 149)	5.21 Units on a scale	Standard Error 0.188
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	Day 14 (n=126, 120, 128)	1.08 Units on a scale	Standard Error 0.14
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	72 Hours PS (n=83, 90, 75)	2.80 Units on a scale	Standard Error 0.239
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	48 Hours PS (n=142, 141, 142)	3.57 Units on a scale	Standard Error 0.185
Pregabalin 150mg	Current Pain - Pain With Movement Caused by Sitting	Discharge (n=141, 135, 144)	2.67 Units on a scale	Standard Error 0.175
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	120 Hours PS (n=14, 15, 12)	2.84 Units on a scale	Standard Error 0.527
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	24 Hours PS (n=147, 141, 149)	5.53 Units on a scale	Standard Error 0.194
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	48 Hours PS (n=142, 141, 142)	3.71 Units on a scale	Standard Error 0.189
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	72 Hours PS (n=83, 90, 75)	3.04 Units on a scale	Standard Error 0.225
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	96 Hours PS (n=29, 31, 26)	3.20 Units on a scale	Standard Error 0.383
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	144 Hours PS (n=2, 5, 5)	1.26 Units on a scale	Standard Error 1.177
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	Discharge (n=141, 135, 144)	2.99 Units on a scale	Standard Error 0.181
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	Day 14 (n=126, 120, 128)	1.37 Units on a scale	Standard Error 0.145
Pregabalin 300 mg	Current Pain - Pain With Movement Caused by Sitting	Day 28 (n=138, 138, 142)	0.91 Units on a scale	Standard Error 0.129
Placebo	Current Pain - Pain With Movement Caused by Sitting	72 Hours PS (n=83, 90, 75)	3.20 Units on a scale	Standard Error 0.257
Placebo	Current Pain - Pain With Movement Caused by Sitting	24 Hours PS (n=147, 141, 149)	5.28 Units on a scale	Standard Error 0.189
Placebo	Current Pain - Pain With Movement Caused by Sitting	Discharge (n=141, 135, 144)	2.42 Units on a scale	Standard Error 0.176
Placebo	Current Pain - Pain With Movement Caused by Sitting	48 Hours PS (n=142, 141, 142)	3.67 Units on a scale	Standard Error 0.189
Placebo	Current Pain - Pain With Movement Caused by Sitting	Day 28 (n=138, 138, 142)	0.76 Units on a scale	Standard Error 0.127
Placebo	Current Pain - Pain With Movement Caused by Sitting	120 Hours PS (n=14, 15, 12)	2.36 Units on a scale	Standard Error 0.633
Placebo	Current Pain - Pain With Movement Caused by Sitting	96 Hours PS (n=29, 31, 26)	3.20 Units on a scale	Standard Error 0.444
Placebo	Current Pain - Pain With Movement Caused by Sitting	Day 14 (n=126, 120, 128)	1.30 Units on a scale	Standard Error 0.143
Placebo	Current Pain - Pain With Movement Caused by Sitting	144 Hours PS (n=2, 5, 5)	2.00 Units on a scale	Standard Error 1.01

Comparison: 24 hours PSp-value: 0.7752ANOVA

Comparison: 24 hours PSp-value: 0.3375ANOVA

Comparison: 48 hours PSp-value: 0.7029ANOVA

Comparison: 48 hours PSp-value: 0.8618ANOVA

Comparison: 72 hours PSp-value: 0.2117ANOVA

Comparison: 72 hours PSp-value: 0.6255ANOVA

Comparison: 96 hours PSp-value: 0.0942ANOVA

Comparison: 96 hours PSp-value: 0.9907ANOVA

Comparison: 120 hours PSp-value: 0.4678ANOVA

Comparison: 120 hours PSp-value: 0.55ANOVA

Comparison: 144 hours PSp-value: 0.9333ANOVA

Comparison: 144 hours PSp-value: 0.7396ANOVA

Comparison: Dischargep-value: 0.2932ANOVA

Comparison: Dischargep-value: 0.0164ANOVA

Comparison: Day 14p-value: 0.2468ANOVA

Comparison: Day 14p-value: 0.7022ANOVA

Comparison: Day 28p-value: 0.7257ANOVA

Comparison: Day 28p-value: 0.3854ANOVA

Secondary

Incidence of Chronic Post-operative Pain

Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.

Time frame: 3 and 6 Months PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit.

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Incidence of Chronic Post-operative Pain	Months 3 PS (n =136, 127, 138)	12.5 Percentage of participants
Pregabalin 150mg	Incidence of Chronic Post-operative Pain	Months 6 PS (n =138, 127, 141)	6.5 Percentage of participants
Pregabalin 300 mg	Incidence of Chronic Post-operative Pain	Months 3 PS (n =136, 127, 138)	17.3 Percentage of participants
Pregabalin 300 mg	Incidence of Chronic Post-operative Pain	Months 6 PS (n =138, 127, 141)	6.3 Percentage of participants
Placebo	Incidence of Chronic Post-operative Pain	Months 3 PS (n =136, 127, 138)	10.1 Percentage of participants
Placebo	Incidence of Chronic Post-operative Pain	Months 6 PS (n =138, 127, 141)	4.3 Percentage of participants

Comparison: Incidence of chronic PS pain at Month 3 PS.p-value: 0.9877Cochran-Mantel-Haenszel

Comparison: Incidence of chronic PS pain at Month 3 PS.p-value: 0.1334Cochran-Mantel-Haenszel

Comparison: Incidence of chronic PS pain at Month 6 PS.p-value: 0.3566Cochran-Mantel-Haenszel

Comparison: Incidence of chronic PS pain at Month 6 PS.p-value: 0.6262Cochran-Mantel-Haenszel

Secondary

Integrated Analgesic Score

The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: 0-24, 24-48, 48-72 hours PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Integrated Analgesic Score	24-48 Hours PS (n=141, 142, 139)	-5.51 Units on a scale	Standard Error 6.979
Pregabalin 150mg	Integrated Analgesic Score	0-24 Hours PS (n=150, 145, 151)	-6.58 Units on a scale	Standard Error 6.795
Pregabalin 150mg	Integrated Analgesic Score	48-72 Hours PS (n=81, 89, 74)	3.23 Units on a scale	Standard Error 9.884
Pregabalin 300 mg	Integrated Analgesic Score	24-48 Hours PS (n=141, 142, 139)	-18.84 Units on a scale	Standard Error 7.051
Pregabalin 300 mg	Integrated Analgesic Score	0-24 Hours PS (n=150, 145, 151)	-11.66 Units on a scale	Standard Error 6.991
Pregabalin 300 mg	Integrated Analgesic Score	48-72 Hours PS (n=81, 89, 74)	-6.93 Units on a scale	Standard Error 9.271
Placebo	Integrated Analgesic Score	0-24 Hours PS (n=150, 145, 151)	3.36 Units on a scale	Standard Error 6.906
Placebo	Integrated Analgesic Score	48-72 Hours PS (n=81, 89, 74)	19.85 Units on a scale	Standard Error 10.568
Placebo	Integrated Analgesic Score	24-48 Hours PS (n=141, 142, 139)	5.48 Units on a scale	Standard Error 7.21

Comparison: 0-24 Hours PSp-value: 0.273ANOVA

Comparison: 0-24 Hours PSp-value: 0.1015ANOVA

Comparison: 24-48 Hours PSp-value: 0.2438ANOVA

Comparison: 24-48 Hours PSp-value: 0.0102ANOVA

Comparison: 48-72 Hours PSp-value: 0.2063ANOVA

Comparison: 48-72 Hours PSp-value: 0.0387ANOVA

Secondary

Non-opioid Rescue Medication - Ibuprofen

The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.

Time frame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	24 Hours PS (n=150, 147, 155)	0.01 Grams (g)	Standard Deviation 0.014
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	48 Hours PS (n=150, 147, 154)	0.08 Grams (g)	Standard Deviation 0.037
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	72 Hours PS (n=150, 147, 149)	0.14 Grams (g)	Standard Deviation 0.064
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	1st Week PS (n=142, 142, 145)	0.51 Grams (g)	Standard Deviation 0.208
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	2nd Week PS (n=140, 135, 143)	1.22 Grams (g)	Standard Deviation 0.413
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	3rd Week PS (n=132, 124, 134)	1.95 Grams (g)	Standard Deviation 0.665
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	4th Week PS (n=95, 94, 103)	2.42 Grams (g)	Standard Deviation 1.041
Pregabalin 150mg	Non-opioid Rescue Medication - Ibuprofen	Till Discharge (n=147, 143, 147)	0.18 Grams (g)	Standard Deviation 0.074
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	72 Hours PS (n=150, 147, 149)	0.27 Grams (g)	Standard Deviation 0.065
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	4th Week PS (n=95, 94, 103)	4.30 Grams (g)	Standard Deviation 1.08
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	1st Week PS (n=142, 142, 145)	0.87 Grams (g)	Standard Deviation 0.21
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	2nd Week PS (n=140, 135, 143)	1.94 Grams (g)	Standard Deviation 0.423
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	3rd Week PS (n=132, 124, 134)	2.99 Grams (g)	Standard Deviation 0.692
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	24 Hours PS (n=150, 147, 155)	0.03 Grams (g)	Standard Deviation 0.014
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	48 Hours PS (n=150, 147, 154)	0.15 Grams (g)	Standard Deviation 0.038
Pregabalin 300 mg	Non-opioid Rescue Medication - Ibuprofen	Till Discharge (n=147, 143, 147)	0.38 Grams (g)	Standard Deviation 0.076
Placebo	Non-opioid Rescue Medication - Ibuprofen	72 Hours PS (n=150, 147, 149)	0.24 Grams (g)	Standard Deviation 0.066
Placebo	Non-opioid Rescue Medication - Ibuprofen	48 Hours PS (n=150, 147, 154)	0.12 Grams (g)	Standard Deviation 0.038
Placebo	Non-opioid Rescue Medication - Ibuprofen	24 Hours PS (n=150, 147, 155)	0.01 Grams (g)	Standard Deviation 0.014
Placebo	Non-opioid Rescue Medication - Ibuprofen	1st Week PS (n=142, 142, 145)	0.97 Grams (g)	Standard Deviation 0.211
Placebo	Non-opioid Rescue Medication - Ibuprofen	4th Week PS (n=95, 94, 103)	3.84 Grams (g)	Standard Deviation 1.038
Placebo	Non-opioid Rescue Medication - Ibuprofen	3rd Week PS (n=132, 124, 134)	2.83 Grams (g)	Standard Deviation 0.679
Placebo	Non-opioid Rescue Medication - Ibuprofen	2nd Week PS (n=140, 135, 143)	1.88 Grams (g)	Standard Deviation 0.42
Placebo	Non-opioid Rescue Medication - Ibuprofen	Till Discharge (n=147, 143, 147)	0.26 Grams (g)	Standard Deviation 0.076

Comparison: 24 hours PSp-value: 0.894ANOVA

Comparison: 24 hours PSp-value: 0.5938ANOVA

Comparison: 48 hours PSp-value: 0.4306ANOVA

Comparison: 48 hours PSp-value: 0.5899ANOVA

Comparison: 72 hours PSp-value: 0.2209ANOVA

Comparison: 72 hours PSp-value: 0.7145ANOVA

Comparison: 1st Week PSp-value: 0.1022ANOVA

Comparison: 1st Week PSp-value: 0.7243ANOVA

Comparison: 2nd Week PSp-value: 0.231ANOVA

Comparison: 2nd Week PSp-value: 0.9192ANOVA

Comparison: 3rd Week PSp-value: 0.3214ANOVA

Comparison: 3rd Week PSp-value: 0.8641ANOVA

Comparison: 4th Week PSp-value: 0.3024ANOVA

Comparison: 4th Week PSp-value: 0.7359ANOVA

Comparison: Till Dischargep-value: 0.4303ANOVA

Comparison: Till Dischargep-value: 0.2133ANOVA

Secondary

Non-opioid Rescue Medication - Paracetamol

The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.

Time frame: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	24 Hours PS (n=150, 147, 155)	1.16 Grams (g)	Standard Deviation 0.098
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	48 Hours PS (n=150, 147, 154)	3.23 Grams (g)	Standard Deviation 0.195
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	72 Hours PS (n=150, 147,149)	5.07 Grams (g)	Standard Deviation 0.294
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	1st Week PS (n=142, 142, 145)	10.76 Grams (g)	Standard Deviation 0.732
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	2nd Week PS (n=139, 135, 143)	17.89 Grams (g)	Standard Deviation 1.711
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	3rd Week PS (n=131, 124, 134)	23.56 Grams (g)	Standard Deviation 2.654
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	4th Week PS (n=95, 94, 103)	27.10 Grams (g)	Standard Deviation 3.313
Pregabalin 150mg	Non-opioid Rescue Medication - Paracetamol	Till Discharge (n=147, 143, 147)	5.45 Grams (g)	Standard Deviation 0.39
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	72 Hours PS (n=150, 147,149)	5.08 Grams (g)	Standard Deviation 0.3
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	4th Week PS (n=95, 94, 103)	25.62 Grams (g)	Standard Deviation 3.437
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	1st Week PS (n=142, 142, 145)	10.57 Grams (g)	Standard Deviation 0.739
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	2nd Week PS (n=139, 135, 143)	16.79 Grams (g)	Standard Deviation 1.747
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	3rd Week PS (n=131, 124, 134)	22.12 Grams (g)	Standard Deviation 2.748
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	24 Hours PS (n=150, 147, 155)	1.21 Grams (g)	Standard Deviation 0.1
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	48 Hours PS (n=150, 147, 154)	3.20 Grams (g)	Standard Deviation 0.199
Pregabalin 300 mg	Non-opioid Rescue Medication - Paracetamol	Till Discharge (n=147, 143, 147)	5.78 Grams (g)	Standard Deviation 0.399
Placebo	Non-opioid Rescue Medication - Paracetamol	72 Hours PS (n=150, 147,149)	5.68 Grams (g)	Standard Deviation 0.301
Placebo	Non-opioid Rescue Medication - Paracetamol	48 Hours PS (n=150, 147, 154)	3.55 Grams (g)	Standard Deviation 0.195
Placebo	Non-opioid Rescue Medication - Paracetamol	24 Hours PS (n=150, 147, 155)	1.22 Grams (g)	Standard Deviation 0.098
Placebo	Non-opioid Rescue Medication - Paracetamol	1st Week PS (n=142, 142, 145)	12.63 Grams (g)	Standard Deviation 0.74
Placebo	Non-opioid Rescue Medication - Paracetamol	4th Week PS (n=95, 94, 103)	25.63 Grams (g)	Standard Deviation 3.301
Placebo	Non-opioid Rescue Medication - Paracetamol	3rd Week PS (n=131, 124, 134)	24.35 Grams (g)	Standard Deviation 2.695
Placebo	Non-opioid Rescue Medication - Paracetamol	2nd Week PS (n=139, 135, 143)	19.70 Grams (g)	Standard Deviation 1.731
Placebo	Non-opioid Rescue Medication - Paracetamol	Till Discharge (n=147, 143, 147)	6.05 Grams (g)	Standard Deviation 0.399

Comparison: 24 hours PSp-value: 0.5995ANOVA

Comparison: 24 Hours PSp-value: 0.9104ANOVA

Comparison: 48 Hours PSp-value: 0.2177ANOVA

Comparison: 48 hours PSp-value: 0.177ANOVA

Comparison: 72 hours PSp-value: 0.1229ANOVA

Comparison: 72 hours PSp-value: 0.1274ANOVA

Comparison: 1st Week PSp-value: 0.0568ANOVA

Comparison: 1st Week PSp-value: 0.0354ANOVA

Comparison: 2nd Week PSp-value: 0.4269ANOVA

Comparison: 2nd Week PSp-value: 0.2058ANOVA

Comparison: 3rd Week PSp-value: 0.8215ANOVA

Comparison: 3rd Week PSp-value: 0.5331ANOVA

Comparison: 4th Week PSp-value: 0.7365ANOVA

Comparison: 4th Week PSp-value: 0.9989ANOVA

Comparison: Till Dischargep-value: 0.2501ANOVA

Comparison: Till Dischargep-value: 0.6021ANOVA

Secondary

Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication

Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Discharge (day 3 up to day 7 PS), Day 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	Discharge (n=139, 141, 140)	72.73 Units on a scale	Standard Error 2.08
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	Day 28 (n=133, 135, 141)	76.41 Units on a scale	Standard Error 2.18
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	Discharge (n=139, 141, 140)	66.28 Units on a scale	Standard Error 2.099
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	Day 28 (n=133, 135, 141)	69.53 Units on a scale	Standard Error 2.181
Placebo	Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	Discharge (n=139, 141, 140)	72.82 Units on a scale	Standard Error 2.159
Placebo	Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	Day 28 (n=133, 135, 141)	69.05 Units on a scale	Standard Error 2.156

Comparison: Dischargep-value: 0.9712ANOVA

Comparison: Dischargep-value: 0.0112ANOVA

Comparison: Day 28p-value: 0.009ANOVA

Comparison: Day 28p-value: 0.865ANOVA

Secondary

Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication

Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Discharge (day 3 up to day 7 PS), Day 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Medication Subscale/Discharge (n=138, 137, 139)	79.43 Units on a scale	Standard Error 1.717
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Medication Subscale/Day 28 (n=133, 134, 137)	82.52 Units on a scale	Standard Error 1.619
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Characteristic Subscale/Discharge (n=138,136,138)	82.15 Units on a scale	Standard Error 1.565
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Characteristic Subscale/Day 28 (n=133, 133, 137)	84.82 Units on a scale	Standard Error 1.448
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Efficacy Subscale/Discharge (n=138, 137, 139)	76.68 Units on a scale	Standard Error 2.264
Pregabalin 150mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Efficacy Subscale/Day 28 (n=133, 134, 136)	80.20 Units on a scale	Standard Error 2.161
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Efficacy Subscale/Day 28 (n=133, 134, 136)	76.92 Units on a scale	Standard Error 2.138
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Medication Subscale/Discharge (n=138, 137, 139)	78.45 Units on a scale	Standard Error 1.747
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Characteristic Subscale/Day 28 (n=133, 133, 137)	83.16 Units on a scale	Standard Error 1.438
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Efficacy Subscale/Discharge (n=138, 137, 139)	75.04 Units on a scale	Standard Error 2.304
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Medication Subscale/Day 28 (n=133, 134, 137)	80.16 Units on a scale	Standard Error 1.601
Pregabalin 300 mg	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Characteristic Subscale/Discharge (n=138,136,138)	81.88 Units on a scale	Standard Error 1.597
Placebo	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Medication Subscale/Day 28 (n=133, 134, 137)	78.26 Units on a scale	Standard Error 1.615
Placebo	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Characteristic Subscale/Discharge (n=138,136,138)	79.58 Units on a scale	Standard Error 1.623
Placebo	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Efficacy Subscale/Day 28 (n=133, 134, 136)	74.82 Units on a scale	Standard Error 2.166
Placebo	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Characteristic Subscale/Day 28 (n=133, 133, 137)	81.69 Units on a scale	Standard Error 1.445
Placebo	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Medication Subscale/Discharge (n=138, 137, 139)	76.71 Units on a scale	Standard Error 1.776
Placebo	Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	Efficacy Subscale/Discharge (n=138, 137, 139)	73.77 Units on a scale	Standard Error 2.342

Comparison: Medication Subscale at Dischargep-value: 0.1872ANOVA

Comparison: Medication Subscale at Dischargep-value: 0.3994ANOVA

Comparison: Medication Subscale at Day 28p-value: 0.0422ANOVA

Comparison: Medication Subscale at Day 28p-value: 0.3647ANOVA

Comparison: Characteristics at Dischargep-value: 0.1729ANOVA

Comparison: Characteristics at Dischargep-value: 0.2234ANOVA

Comparison: Characteristics at Day 28p-value: 0.095ANOVA

Comparison: Characteristics at Day 28p-value: 0.4345ANOVA

Comparison: Efficacy at Dischargep-value: 0.284ANOVA

Comparison: Efficacy at Dischargep-value: 0.6404ANOVA

Comparison: Efficacy at Day 28p-value: 0.055ANOVA

Comparison: Efficacy at Day 28p-value: 0.4531ANOVA

Secondary

Participant Satisfaction With Study Medication - Day 14 PS

Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.

Time frame: Day 14 PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 14 PS	Poor	6.2 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 14 PS	Excellent	40.0 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 14 PS	Fair	11.5 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 14 PS	Good	42.3 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 14 PS	Fair	16.7 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 14 PS	Poor	3.2 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 14 PS	Good	37.3 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 14 PS	Excellent	42.9 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 14 PS	Poor	10.7 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 14 PS	Good	33.6 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 14 PS	Fair	24.4 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 14 PS	Excellent	31.3 Percentage of participants

Comparison: Day 14p-value: 0.0206Cochran-Mantel-Haenszel

Comparison: Day 14p-value: 0.0011Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Day 1 PS

Time frame: Day 1 PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 1 PS	Excellent	13.3 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 1 PS	Good	56.0 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 1 PS	Fair	26.7 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 1 PS	Poor	4.0 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 1 PS	Poor	6.1 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 1 PS	Excellent	17.6 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 1 PS	Fair	29.1 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 1 PS	Good	47.3 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 1 PS	Poor	7.8 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 1 PS	Good	45.5 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 1 PS	Fair	30.5 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 1 PS	Excellent	16.2 Percentage of participants

Comparison: Day 1 PSp-value: 0.4264Cochran-Mantel-Haenszel

Comparison: Day 1 PSp-value: 0.3045Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Day 28 PS

Time frame: Day 28 PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 28 PS	Excellent	42.4 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 28 PS	Good	41.7 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 28 PS	Fair	9.4 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 28 PS	Poor	6.5 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 28 PS	Poor	9.2 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 28 PS	Excellent	40.1 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 28 PS	Fair	16.2 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 28 PS	Good	34.5 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 28 PS	Poor	7.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 28 PS	Good	35.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 28 PS	Fair	23.8 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 28 PS	Excellent	34.3 Percentage of participants

Comparison: Day 28p-value: 0.0287Cochran-Mantel-Haenszel

Comparison: Day 28p-value: 0.227Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Day 2 PS

Time frame: Day 2 PS

Population: mITT; N=number of evaluable participants analyzed;

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 2 PS	Excellent	21.9 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 2 PS	Good	49.1 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 2 PS	Fair	25.4 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 2 PS	Poor	3.5 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 2 PS	Good	54.6 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 2 PS	Excellent	17.6 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 2 PS	Poor	5.9 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 2 PS	Fair	21.8 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 2 PS	Excellent	16.2 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 2 PS	Fair	29.1 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 2 PS	Good	47.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 2 PS	Poor	7.7 Percentage of participants

Comparison: Day 2 PSp-value: 0.0714Cochran-Mantel-Haenszel

Comparison: Day 2 PSp-value: 0.4455Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Day 3 PS

Time frame: Day 3 PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 3 PS	Excellent	15.9 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 3 PS	Good	52.3 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 3 PS	Fair	31.8 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 3 PS	Poor	0 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 3 PS	Poor	5.0 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 3 PS	Excellent	17.5 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 3 PS	Fair	30.0 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 3 PS	Good	47.5 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 3 PS	Poor	2.9 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 3 PS	Good	50.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 3 PS	Fair	29.4 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 3 PS	Excellent	17.6 Percentage of participants

Comparison: Day 3 PSp-value: 0.7418Cochran-Mantel-Haenszel

Comparison: Day 3 PSp-value: 0.5154Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Day 4 PS

Time frame: Day 4 PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 4 PS	Excellent	17.6 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 4 PS	Good	52.9 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 4 PS	Fair	29.4 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 4 PS	Poor	0 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 4 PS	Poor	5.3 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 4 PS	Excellent	5.3 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 4 PS	Fair	31.6 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 4 PS	Good	57.9 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 4 PS	Poor	14.3 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 4 PS	Good	42.9 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 4 PS	Fair	28.6 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 4 PS	Excellent	14.3 Percentage of participants

Comparison: Day 4 PSp-value: 0.6715Cochran-Mantel-Haenszel

Comparison: Day 4 PSp-value: 0.9013Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Day 5 PS

Time frame: Day 5 PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 5 PS	Excellent	0 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 5 PS	Good	71.4 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 5 PS	Fair	28.6 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 5 PS	Poor	0 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 5 PS	Poor	0 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 5 PS	Excellent	7.7 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 5 PS	Fair	38.5 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 5 PS	Good	53.8 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 5 PS	Poor	14.3 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 5 PS	Good	42.9 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 5 PS	Fair	28.6 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 5 PS	Excellent	14.3 Percentage of participants

Comparison: Day 5 PSp-value: 0.9126Cochran-Mantel-Haenszel

Comparison: Day 5 PSp-value: 1Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Day 7 PS

Time frame: Day 7 PS

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 7 PS	Excellent	36.6 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 7 PS	Good	38.2 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 7 PS	Fair	15.4 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Day 7 PS	Poor	9.8 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 7 PS	Poor	8.2 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 7 PS	Excellent	36.9 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 7 PS	Fair	17.2 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Day 7 PS	Good	37.7 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 7 PS	Poor	9.4 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 7 PS	Good	39.4 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 7 PS	Fair	26.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Day 7 PS	Excellent	25.2 Percentage of participants

Comparison: Day 7p-value: 0.0361Cochran-Mantel-Haenszel

Comparison: Day 7p-value: 0.0797Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Discharge

Time frame: Discharge (day 3 up to day 7 PS)

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Discharge	Excellent	29.6 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Discharge	Good	48.6 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Discharge	Fair	16.9 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Discharge	Poor	4.9 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Discharge	Poor	4.8 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Discharge	Excellent	26.2 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Discharge	Fair	17.9 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Discharge	Good	51.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Discharge	Poor	8.8 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Discharge	Good	39.9 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Discharge	Fair	25.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Discharge	Excellent	26.4 Percentage of participants

Comparison: Dischargep-value: 0.1233Cochran-Mantel-Haenszel

Comparison: Dischargep-value: 0.1666Cochran-Mantel-Haenszel

Secondary

Participant Satisfaction With Study Medication - Surgery Day

Time frame: Day 1

Population: mITT; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Participant Satisfaction With Study Medication - Surgery Day	Excellent	14.3 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Surgery Day	Good	42.9 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Surgery Day	Fair	39.3 Percentage of participants
Pregabalin 150mg	Participant Satisfaction With Study Medication - Surgery Day	Poor	3.6 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Surgery Day	Poor	3.1 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Surgery Day	Excellent	3.1 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Surgery Day	Fair	31.3 Percentage of participants
Pregabalin 300 mg	Participant Satisfaction With Study Medication - Surgery Day	Good	62.5 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Surgery Day	Poor	15.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Surgery Day	Good	35.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Surgery Day	Fair	30.0 Percentage of participants
Placebo	Participant Satisfaction With Study Medication - Surgery Day	Excellent	20.0 Percentage of participants

Comparison: Surgery Dayp-value: 0.6861Cochran-Mantel-Haenszel

Comparison: Surgery Dayp-value: 0.9905Cochran-Mantel-Haenszel

Secondary

Percent Change From Baseline in Peak Expiratory Flow

Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	88 Hours PS (n=18, 15, 19)	-10.08 L/min	Standard Error 8.257
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	48 Hours PS (n=108, 112, 111)	-16.71 L/min	Standard Error 3.203
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	8 Hours PS (n=84, 79, 83)	-39.25 L/min	Standard Error 3.081
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	Baseline (n=116, 114, 121)	0 L/min	Standard Error 0
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	56 Hours PS (n=78, 85, 82)	-17.11 L/min	Standard Error 3.76
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	112 Hours PS (n=5, 10, 9)	-15.61 L/min	Standard Error 15.629
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	80 Hours PS (n=30, 24, 24)	-17.23 L/min	Standard Error 7.29
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	64 Hours PS (n=52, 51, 54)	-15.04 L/min	Standard Error 4.672
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	24 Hours PS (n=115, 112, 117)	-28.92 L/min	Standard Error 3.084
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	72 Hours PS (n=61, 68, 60)	-18.12 L/min	Standard Error 5.27
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	128 Hours PS (n=4, 9, 7)	-6.72 L/min	Standard Error 13.735
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	104 Hours PS (n=9, 12, 12)	-12.79 L/min	Standard Error 10.574
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	32 Hours PS (n=104, 105, 106)	-24.53 L/min	Standard Error 3.51
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	120 Hours PS (n=10, 12, 10)	-12.36 L/min	Standard Error 11.386
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	96 Hours PS (n=20, 22, 21)	-1.45 L/min	Standard Error 9.063
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	40 Hours PS (n=70, 73, 79)	-24.18 L/min	Standard Error 3.575
Pregabalin 150mg	Percent Change From Baseline in Peak Expiratory Flow	16 Hours PS (n=72, 62, 76)	-37.37 L/min	Standard Error 3.454
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	80 Hours PS (n=30, 24, 24)	-3.01 L/min	Standard Error 7.75
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	Baseline (n=116, 114, 121)	0 L/min	Standard Error 0
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	8 Hours PS (n=84, 79, 83)	-35.35 L/min	Standard Error 3.307
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	16 Hours PS (n=72, 62, 76)	-36.49 L/min	Standard Error 3.764
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	24 Hours PS (n=115, 112, 117)	-26.53 L/min	Standard Error 3.212
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	32 Hours PS (n=104, 105, 106)	-25.66 L/min	Standard Error 3.644
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	40 Hours PS (n=70, 73, 79)	-25.70 L/min	Standard Error 3.663
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	48 Hours PS (n=108, 112, 111)	-13.62 L/min	Standard Error 3.255
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	56 Hours PS (n=78, 85, 82)	-15.40 L/min	Standard Error 3.771
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	64 Hours PS (n=52, 51, 54)	-14.20 L/min	Standard Error 5.028
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	72 Hours PS (n=61, 68, 60)	-12.97 L/min	Standard Error 4.792
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	88 Hours PS (n=18, 15, 19)	-2.30 L/min	Standard Error 8.818
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	96 Hours PS (n=20, 22, 21)	5.26 L/min	Standard Error 8.585
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	104 Hours PS (n=9, 12, 12)	0.69 L/min	Standard Error 9.428
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	112 Hours PS (n=5, 10, 9)	8.49 L/min	Standard Error 10.863
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	120 Hours PS (n=10, 12, 10)	-8.14 L/min	Standard Error 10.307
Pregabalin 300 mg	Percent Change From Baseline in Peak Expiratory Flow	128 Hours PS (n=4, 9, 7)	-4.76 L/min	Standard Error 8.166
Placebo	Percent Change From Baseline in Peak Expiratory Flow	8 Hours PS (n=84, 79, 83)	-41.29 L/min	Standard Error 3.242
Placebo	Percent Change From Baseline in Peak Expiratory Flow	88 Hours PS (n=18, 15, 19)	-9.71 L/min	Standard Error 6.636
Placebo	Percent Change From Baseline in Peak Expiratory Flow	32 Hours PS (n=104, 105, 106)	-28.92 L/min	Standard Error 3.632
Placebo	Percent Change From Baseline in Peak Expiratory Flow	128 Hours PS (n=4, 9, 7)	-14.32 L/min	Standard Error 10.711
Placebo	Percent Change From Baseline in Peak Expiratory Flow	96 Hours PS (n=20, 22, 21)	2.36 L/min	Standard Error 9.11
Placebo	Percent Change From Baseline in Peak Expiratory Flow	24 Hours PS (n=115, 112, 117)	-29.46 L/min	Standard Error 3.058
Placebo	Percent Change From Baseline in Peak Expiratory Flow	120 Hours PS (n=10, 12, 10)	-6.98 L/min	Standard Error 12.201
Placebo	Percent Change From Baseline in Peak Expiratory Flow	104 Hours PS (n=9, 12, 12)	-4.94 L/min	Standard Error 10.21
Placebo	Percent Change From Baseline in Peak Expiratory Flow	16 Hours PS (n=72, 62, 76)	-36.48 L/min	Standard Error 3.395
Placebo	Percent Change From Baseline in Peak Expiratory Flow	Baseline (n=116, 114, 121)	0 L/min	Standard Error 0
Placebo	Percent Change From Baseline in Peak Expiratory Flow	64 Hours PS (n=52, 51, 54)	-17.18 L/min	Standard Error 4.392
Placebo	Percent Change From Baseline in Peak Expiratory Flow	112 Hours PS (n=5, 10, 9)	-11.61 L/min	Standard Error 10.7
Placebo	Percent Change From Baseline in Peak Expiratory Flow	72 Hours PS (n=61, 68, 60)	-20.81 L/min	Standard Error 5.059
Placebo	Percent Change From Baseline in Peak Expiratory Flow	56 Hours PS (n=78, 85, 82)	-21.12 L/min	Standard Error 3.726
Placebo	Percent Change From Baseline in Peak Expiratory Flow	48 Hours PS (n=108, 112, 111)	-21.70 L/min	Standard Error 3.162
Placebo	Percent Change From Baseline in Peak Expiratory Flow	80 Hours PS (n=30, 24, 24)	-8.17 L/min	Standard Error 7.443
Placebo	Percent Change From Baseline in Peak Expiratory Flow	40 Hours PS (n=70, 73, 79)	-25.07 L/min	Standard Error 3.449

Comparison: 8 hours PSp-value: 0.5682ANOVA

Comparison: 8 hours PSp-value: 0.1005ANOVA

Comparison: 16 hours PSp-value: 0.8261ANOVA

Comparison: 16 hours PSp-value: 0.9981ANOVA

Comparison: 24 hours PSp-value: 0.8884ANOVA

Comparison: 24 hours PSp-value: 0.4507ANOVA

Comparison: 32 hours PSp-value: 0.2994ANOVA

Comparison: 32 hours PSp-value: 0.4371ANOVA

Comparison: 40 hours PSp-value: 0.8295ANOVA

Comparison: 40 hours PSp-value: 0.8783ANOVA

Comparison: 48 hours PSp-value: 0.2161ANOVA

Comparison: 48 hours PSp-value: 0.044ANOVA

Comparison: 56 hours PSp-value: 0.3855ANOVA

Comparison: 56 hours PSp-value: 0.201ANOVA

Comparison: 64 hours PSp-value: 0.7104ANOVA

Comparison: 64 hours PSp-value: 0.6107ANOVA

Comparison: 72 hours PSp-value: 0.6705ANOVA

Comparison: 72 hours PSp-value: 0.2083ANOVA

Comparison: 80 hours PSp-value: 0.3234ANOVA

Comparison: 80 hours PSp-value: 0.5938ANOVA

Comparison: 88 hours PSp-value: 0.9711ANOVA

Comparison: 88 hours PSp-value: 0.4869ANOVA

Comparison: 96 hours PSp-value: 0.7439ANOVA

Comparison: 96 hours PSp-value: 0.8045ANOVA

Comparison: 104 hours PSp-value: 0.5925ANOVA

Comparison: 104 hours PSp-value: 0.683ANOVA

Comparison: 112 hours PSp-value: 0.8266ANOVA

Comparison: 112 hours PSp-value: 0.1929ANOVA

Comparison: 120 hours PSp-value: 0.7071ANOVA

Comparison: 120 hours PSp-value: 0.9367ANOVA

Comparison: 128 hours PSp-value: 0.6046ANOVA

Comparison: 128 hours PSp-value: 0.5119ANOVA

Secondary

Quality of Life Using EuroQol (EQ-5D) Health State Profile

Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, confined to bed). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata.

Time frame: Discharge (day 3 up to day 7 PS) and day 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 1997, Discharge (n=138, 141, 138)	0.57 Units on a scale	Standard Error 0.021
Pregabalin 150mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 1997, Day 28 (n=140, 143, 142)	0.81 Units on a scale	Standard Error 0.014
Pregabalin 150mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 2001, Discharge (n=138, 141, 138)	0.59 Units on a scale	Standard Error 0.018
Pregabalin 150mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 2001, Day 28 (n=140, 143, 142)	0.81 Units on a scale	Standard Error 0.014
Pregabalin 300 mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 2001, Day 28 (n=140, 143, 142)	0.78 Units on a scale	Standard Error 0.014
Pregabalin 300 mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 1997, Discharge (n=138, 141, 138)	0.61 Units on a scale	Standard Error 0.021
Pregabalin 300 mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 2001, Discharge (n=138, 141, 138)	0.62 Units on a scale	Standard Error 0.018
Pregabalin 300 mg	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 1997, Day 28 (n=140, 143, 142)	0.78 Units on a scale	Standard Error 0.014
Placebo	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 2001, Day 28 (n=140, 143, 142)	0.78 Units on a scale	Standard Error 0.014
Placebo	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 1997, Day 28 (n=140, 143, 142)	0.78 Units on a scale	Standard Error 0.014
Placebo	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 2001, Discharge (n=138, 141, 138)	0.60 Units on a scale	Standard Error 0.019
Placebo	Quality of Life Using EuroQol (EQ-5D) Health State Profile	EQ-5D 1997, Discharge (n=138, 141, 138)	0.58 Units on a scale	Standard Error 0.022

Comparison: EQ-5D 1997 Dischargep-value: 0.8914ANOVA

Comparison: EQ-5D 1997 Dischargep-value: 0.2214ANOVA

Comparison: EQ-5D 1997 Day 28p-value: 0.1008ANOVA

Comparison: EQ-5D 1997 Day 28p-value: 0.9135ANOVA

Comparison: EQ-5D 2001 Dischargep-value: 0.5609ANOVA

Comparison: EQ-5D 2001 Dischargep-value: 0.4047ANOVA

Comparison: EQ-5D 2001 Day 28p-value: 0.1663ANOVA

Comparison: EQ-5D 2001 Day 28p-value: 0.8364ANOVA

Secondary

Sleep Interference

Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Sleep Interference	Day 5 PS (n=133, 117, 132)	2.1 Units on a scale	Standard Error 0.22
Pregabalin 150mg	Sleep Interference	4th Week PS (Average) (n=87, 87, 81)	1.0 Units on a scale	Standard Error 0.21
Pregabalin 150mg	Sleep Interference	Day 7 PS (n=132, 131, 138)	1.7 Units on a scale	Standard Error 0.22
Pregabalin 150mg	Sleep Interference	Day 6 PS (n=133, 127, 138)	1.7 Units on a scale	Standard Error 0.22
Pregabalin 150mg	Sleep Interference	Day 2 PS (n=21, 18, 20)	2.4 Units on a scale	Standard Error 0.65
Pregabalin 150mg	Sleep Interference	3rd Week PS (Average) (n=115, 112, 113)	1.0 Units on a scale	Standard Error 0.16
Pregabalin 150mg	Sleep Interference	Day 4 PS (n=122, 111, 119)	2.3 Units on a scale	Standard Error 0.24
Pregabalin 150mg	Sleep Interference	Day 3 PS (n=88, 89, 87)	2.6 Units on a scale	Standard Error 0.32
Pregabalin 150mg	Sleep Interference	2nd Week PS (Average) (n=134, 131, 139)	1.3 Units on a scale	Standard Error 0.16
Pregabalin 300 mg	Sleep Interference	Day 6 PS (n=133, 127, 138)	1.9 Units on a scale	Standard Error 0.23
Pregabalin 300 mg	Sleep Interference	Day 2 PS (n=21, 18, 20)	3.6 Units on a scale	Standard Error 0.67
Pregabalin 300 mg	Sleep Interference	Day 3 PS (n=88, 89, 87)	2.3 Units on a scale	Standard Error 0.33
Pregabalin 300 mg	Sleep Interference	Day 4 PS (n=122, 111, 119)	2.5 Units on a scale	Standard Error 0.27
Pregabalin 300 mg	Sleep Interference	Day 5 PS (n=133, 117, 132)	2.2 Units on a scale	Standard Error 0.24
Pregabalin 300 mg	Sleep Interference	Day 7 PS (n=132, 131, 138)	2.0 Units on a scale	Standard Error 0.22
Pregabalin 300 mg	Sleep Interference	2nd Week PS (Average) (n=134, 131, 139)	1.7 Units on a scale	Standard Error 0.17
Pregabalin 300 mg	Sleep Interference	3rd Week PS (Average) (n=115, 112, 113)	1.3 Units on a scale	Standard Error 0.16
Pregabalin 300 mg	Sleep Interference	4th Week PS (Average) (n=87, 87, 81)	1.4 Units on a scale	Standard Error 0.21
Placebo	Sleep Interference	Day 4 PS (n=122, 111, 119)	2.5 Units on a scale	Standard Error 0.26
Placebo	Sleep Interference	Day 2 PS (n=21, 18, 20)	3.2 Units on a scale	Standard Error 0.77
Placebo	Sleep Interference	2nd Week PS (Average) (n=134, 131, 139)	1.5 Units on a scale	Standard Error 0.16
Placebo	Sleep Interference	Day 3 PS (n=88, 89, 87)	2.6 Units on a scale	Standard Error 0.33
Placebo	Sleep Interference	4th Week PS (Average) (n=87, 87, 81)	0.9 Units on a scale	Standard Error 0.22
Placebo	Sleep Interference	Day 6 PS (n=133, 127, 138)	2.1 Units on a scale	Standard Error 0.22
Placebo	Sleep Interference	Day 5 PS (n=133, 117, 132)	2.5 Units on a scale	Standard Error 0.22
Placebo	Sleep Interference	3rd Week PS (Average) (n=115, 112, 113)	1.0 Units on a scale	Standard Error 0.17
Placebo	Sleep Interference	Day 7 PS (n=132, 131, 138)	2.1 Units on a scale	Standard Error 0.22

Comparison: Day 2 PSp-value: 0.3323ANOVA

Comparison: Day 2 PSp-value: 0.5662ANOVA

Comparison: Day 3 PSp-value: 0.9538ANOVA

Comparison: Day 3 PSp-value: 0.4592ANOVA

Comparison: Day 4 PSp-value: 0.4793ANOVA

Comparison: Day 4 PSp-value: 0.8517ANOVA

Comparison: Day 5 PSp-value: 0.1829ANOVA

Comparison: Day 5 PSp-value: 0.3544ANOVA

Comparison: Day 6 PSp-value: 0.1718ANOVA

Comparison: Day 6 PSp-value: 0.5078ANOVA

Comparison: Day 7 PSp-value: 0.2443ANOVA

Comparison: Day 7 PSp-value: 0.8296ANOVA

Comparison: 2nd Week PS (Average)p-value: 0.3243ANOVA

Comparison: 2nd Week PS (Average)p-value: 0.3755ANOVA

Comparison: 3rd Week PS (Average)p-value: 0.9584ANOVA

Comparison: 3rd Week PS (Average)p-value: 0.1187ANOVA

Comparison: 4th Week PS (Average)p-value: 0.7915ANOVA

Comparison: 4th Week PS (Average)p-value: 0.0703ANOVA

Secondary

Timed Up-and-Go (TUG)

Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Timed Up-and-Go (TUG)	Day 1 PS (n=85, 85, 93)	39.77 Seconds	Standard Error 2.558
Pregabalin 150mg	Timed Up-and-Go (TUG)	Day 2 PS (n=107, 105, 105)	31.82 Seconds	Standard Error 1.776
Pregabalin 150mg	Timed Up-and-Go (TUG)	Day 3 PS (n=43, 35, 31)	34.07 Seconds	Standard Error 2.779
Pregabalin 150mg	Timed Up-and-Go (TUG)	Day 4 PS (n=16, 18, 13)	42.26 Seconds	Standard Error 4.591
Pregabalin 150mg	Timed Up-and-Go (TUG)	Day 5 PS (n=7, 10, 7)	31.27 Seconds	Standard Error 5.295
Pregabalin 150mg	Timed Up-and-Go (TUG)	Discharge (n=130, 134, 134)	28.11 Seconds	Standard Error 1.604
Pregabalin 300 mg	Timed Up-and-Go (TUG)	Discharge (n=130, 134, 134)	30.05 Seconds	Standard Error 1.569
Pregabalin 300 mg	Timed Up-and-Go (TUG)	Day 1 PS (n=85, 85, 93)	42.79 Seconds	Standard Error 2.769
Pregabalin 300 mg	Timed Up-and-Go (TUG)	Day 4 PS (n=16, 18, 13)	37.31 Seconds	Standard Error 4.065
Pregabalin 300 mg	Timed Up-and-Go (TUG)	Day 5 PS (n=7, 10, 7)	23.06 Seconds	Standard Error 3.704
Pregabalin 300 mg	Timed Up-and-Go (TUG)	Day 2 PS (n=107, 105, 105)	33.06 Seconds	Standard Error 1.878
Pregabalin 300 mg	Timed Up-and-Go (TUG)	Day 3 PS (n=43, 35, 31)	33.48 Seconds	Standard Error 2.781
Placebo	Timed Up-and-Go (TUG)	Day 2 PS (n=107, 105, 105)	29.25 Seconds	Standard Error 1.845
Placebo	Timed Up-and-Go (TUG)	Day 3 PS (n=43, 35, 31)	31.38 Seconds	Standard Error 2.96
Placebo	Timed Up-and-Go (TUG)	Discharge (n=130, 134, 134)	26.40 Seconds	Standard Error 1.582
Placebo	Timed Up-and-Go (TUG)	Day 4 PS (n=16, 18, 13)	40.43 Seconds	Standard Error 5.275
Placebo	Timed Up-and-Go (TUG)	Day 1 PS (n=85, 85, 93)	38.54 Seconds	Standard Error 2.611
Placebo	Timed Up-and-Go (TUG)	Day 5 PS (n=7, 10, 7)	32.18 Seconds	Standard Error 5.326

Comparison: Day 1 PSp-value: 0.6966ANOVA

Comparison: Day 1 PSp-value: 0.1808ANOVA

Comparison: Day 2 PSp-value: 0.2616ANOVA

Comparison: Day 2 PSp-value: 0.1014ANOVA

Comparison: Day 3 PSp-value: 0.4401ANOVA

Comparison: Day 3 PSp-value: 0.5615ANOVA

Comparison: Day 4 PSp-value: 0.7615ANOVA

Comparison: Day 4 PSp-value: 0.6204ANOVA

Comparison: Day 5 PSp-value: 0.8766ANOVA

Comparison: Day 5 PSp-value: 0.1717ANOVA

Comparison: Dischargep-value: 0.4065ANOVA

Comparison: Dischargep-value: 0.0746ANOVA

Secondary

Time to Actual Discharge

Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.

Time frame: Day 1 up to Day 7 PS

Population: mITT

Arm	Measure	Value (MEAN)	Dispersion
Pregabalin 150mg	Time to Actual Discharge	79.339 Hours	Standard Error 2.547
Pregabalin 300 mg	Time to Actual Discharge	85.221 Hours	Standard Error 3.935
Placebo	Time to Actual Discharge	78.740 Hours	Standard Error 2.441

Comparison: Kaplan-Meier method was used for survival distribution estimation;p-value: 0.7889Log Rank

Comparison: Kaplan-Meier method was used for survival distribution estimation;p-value: 0.1565Log Rank

Secondary

Time to Meet Hospital Discharge Criteria

Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.

Time frame: Day 1 up to Day 7 PS

Population: mITT

Arm	Measure	Value (MEAN)	Dispersion
Pregabalin 150mg	Time to Meet Hospital Discharge Criteria	57.670 Hours	Standard Error 2.829
Pregabalin 300 mg	Time to Meet Hospital Discharge Criteria	60.751 Hours	Standard Error 2.678
Placebo	Time to Meet Hospital Discharge Criteria	58.745 Hours	Standard Error 2.786

Comparison: Kaplan-Meier method was used for survival distribution estimation;p-value: 0.7218Log Rank

Comparison: Kaplan-Meier method was used for survival distribution estimation;p-value: 0.4425Log Rank

Secondary

Total Clinically Meaningful Event (CME) Score

Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Discharge (n=133, 132, 133)	0.4 Units on a scale	Standard Error 0.09
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 2 PS (n=108, 116, 114)	0.6 Units on a scale	Standard Error 0.12
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 7 PS (n=119, 117, 120)	0.2 Units on a scale	Standard Error 0.06
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 14 PS (n=119, 116, 124)	0.1 Units on a scale	Standard Error 0.06
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Surgery Day (n=26, 25, 32)	0.9 Units on a scale	Standard Error 0.29
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 28 PS (n=129, 135, 136)	0.0 Units on a scale	Standard Error 0.06
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 3 PS (n=38, 36, 32)	0.5 Units on a scale	Standard Error 0.19
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 1 PS (n=148, 147, 154)	1.1 Units on a scale	Standard Error 0.13
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 4 PS (n=14, 16, 11)	0.0 Units on a scale	Standard Error 0.19
Pregabalin 150mg	Total Clinically Meaningful Event (CME) Score	Day 5 PS (n=5, 9, 6)	0.4 Units on a scale	Standard Error 0.19
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Discharge (n=133, 132, 133)	0.4 Units on a scale	Standard Error 0.09
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 3 PS (n=38, 36, 32)	0.7 Units on a scale	Standard Error 0.17
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 5 PS (n=5, 9, 6)	0.1 Units on a scale	Standard Error 0.13
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 7 PS (n=119, 117, 120)	0.4 Units on a scale	Standard Error 0.06
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 2 PS (n=108, 116, 114)	0.6 Units on a scale	Standard Error 0.12
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Surgery Day (n=26, 25, 32)	0.8 Units on a scale	Standard Error 0.3
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 14 PS (n=119, 116, 124)	0.2 Units on a scale	Standard Error 0.06
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 4 PS (n=14, 16, 11)	0.4 Units on a scale	Standard Error 0.15
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 28 PS (n=129, 135, 136)	0.2 Units on a scale	Standard Error 0.06
Pregabalin 300 mg	Total Clinically Meaningful Event (CME) Score	Day 1 PS (n=148, 147, 154)	1.1 Units on a scale	Standard Error 0.13
Placebo	Total Clinically Meaningful Event (CME) Score	Day 28 PS (n=129, 135, 136)	0.2 Units on a scale	Standard Error 0.06
Placebo	Total Clinically Meaningful Event (CME) Score	Surgery Day (n=26, 25, 32)	0.9 Units on a scale	Standard Error 0.26
Placebo	Total Clinically Meaningful Event (CME) Score	Day 1 PS (n=148, 147, 154)	1.2 Units on a scale	Standard Error 0.13
Placebo	Total Clinically Meaningful Event (CME) Score	Day 2 PS (n=108, 116, 114)	0.7 Units on a scale	Standard Error 0.12
Placebo	Total Clinically Meaningful Event (CME) Score	Day 3 PS (n=38, 36, 32)	0.3 Units on a scale	Standard Error 0.19
Placebo	Total Clinically Meaningful Event (CME) Score	Day 4 PS (n=14, 16, 11)	0.3 Units on a scale	Standard Error 0.22
Placebo	Total Clinically Meaningful Event (CME) Score	Day 5 PS (n=5, 9, 6)	0.3 Units on a scale	Standard Error 0.18
Placebo	Total Clinically Meaningful Event (CME) Score	Discharge (n=133, 132, 133)	0.3 Units on a scale	Standard Error 0.09
Placebo	Total Clinically Meaningful Event (CME) Score	Day 7 PS (n=119, 117, 120)	0.2 Units on a scale	Standard Error 0.06
Placebo	Total Clinically Meaningful Event (CME) Score	Day 14 PS (n=119, 116, 124)	0.1 Units on a scale	Standard Error 0.06

Comparison: Surgery day;p-value: 0.9463ANOVA

Comparison: Surgery day;p-value: 0.7347ANOVA

Comparison: Day 1 PS;p-value: 0.4132ANOVA

Comparison: Day 1 PS;p-value: 0.4929ANOVA

Comparison: Day 2 PS;p-value: 0.6003ANOVA

Comparison: Day 2 PS;p-value: 0.9343ANOVA

Comparison: Day 3 PS;p-value: 0.3838ANOVA

Comparison: Day 3 PS;p-value: 0.1351ANOVA

Comparison: Day 4 PS;p-value: 0.3343ANOVA

Comparison: Day 4 PS;p-value: 0.7948ANOVA

Comparison: Day 5 PS;p-value: 0.809ANOVA

Comparison: Day 5 PS;p-value: 0.4035ANOVA

Comparison: Dischargep-value: 0.6009ANOVA

Comparison: Dischargep-value: 0.7597ANOVA

Comparison: Day 7p-value: 0.7804ANOVA

Comparison: Day 7p-value: 0.0463ANOVA

Comparison: Day 14p-value: 0.4951ANOVA

Comparison: Day 14p-value: 0.303ANOVA

Comparison: Day 28p-value: 0.0104ANOVA

Comparison: Day 28p-value: 0.6978ANOVA

Secondary

Total Cumulative Dose of Opioids Following Surgery

Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: 24, 48 Hours PS, Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Total Cumulative Dose of Opioids Following Surgery	48 hours PS (n=150, 147, 151)	148.67 milligram (mg)	Standard Error 9.218
Pregabalin 150mg	Total Cumulative Dose of Opioids Following Surgery	24 hours PS (n=150, 147, 153)	113.38 milligram (mg)	Standard Error 7.078
Pregabalin 150mg	Total Cumulative Dose of Opioids Following Surgery	Till Discharge (n=147, 143, 144)	164.28 milligram (mg)	Standard Error 11.161
Pregabalin 300 mg	Total Cumulative Dose of Opioids Following Surgery	48 hours PS (n=150, 147, 151)	144.95 milligram (mg)	Standard Error 9.391
Pregabalin 300 mg	Total Cumulative Dose of Opioids Following Surgery	24 hours PS (n=150, 147, 153)	111.27 milligram (mg)	Standard Error 7.211
Pregabalin 300 mg	Total Cumulative Dose of Opioids Following Surgery	Till Discharge (n=147, 143, 144)	167.01 milligram (mg)	Standard Error 11.41
Placebo	Total Cumulative Dose of Opioids Following Surgery	24 hours PS (n=150, 147, 153)	124.44 milligram (mg)	Standard Error 7.16
Placebo	Total Cumulative Dose of Opioids Following Surgery	Till Discharge (n=147, 143, 144)	195.32 milligram (mg)	Standard Error 11.569
Placebo	Total Cumulative Dose of Opioids Following Surgery	48 hours PS (n=150, 147, 151)	168.31 milligram (mg)	Standard Error 9.372

Comparison: 24 hours PSp-value: 0.2409ANOVA

Comparison: 24 hours PSp-value: 0.1654ANOVA

Comparison: 48 hours PSp-value: 0.111ANOVA

Comparison: 48 hours PSp-value: 0.0598ANOVA

Comparison: Till Dischargep-value: 0.0398ANOVA

Comparison: Till Dischargep-value: 0.0623ANOVA

Secondary

Worst Daily Pain

Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.

Time frame: Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
Pregabalin 150mg	Worst Daily Pain	Discharge (n=140, 143, 138)	4.3 Units on a scale	Standard Deviation 0.22
Pregabalin 150mg	Worst Daily Pain	Day 7 (n=123, 121, 125)	3.2 Units on a scale	Standard Deviation 0.24
Pregabalin 150mg	Worst Daily Pain	Day 14 (n=129, 125, 130)	1.8 Units on a scale	Standard Deviation 0.19
Pregabalin 150mg	Worst Daily Pain	Day 28 (n=141, 142, 143)	1.2 Units on a scale	Standard Deviation 0.15
Pregabalin 300 mg	Worst Daily Pain	Day 28 (n=141, 142, 143)	1.7 Units on a scale	Standard Deviation 0.15
Pregabalin 300 mg	Worst Daily Pain	Discharge (n=140, 143, 138)	4.4 Units on a scale	Standard Deviation 0.22
Pregabalin 300 mg	Worst Daily Pain	Day 14 (n=129, 125, 130)	2.4 Units on a scale	Standard Deviation 0.19
Pregabalin 300 mg	Worst Daily Pain	Day 7 (n=123, 121, 125)	3.4 Units on a scale	Standard Deviation 0.24
Placebo	Worst Daily Pain	Day 28 (n=141, 142, 143)	1.4 Units on a scale	Standard Deviation 0.15
Placebo	Worst Daily Pain	Day 7 (n=123, 121, 125)	3.5 Units on a scale	Standard Deviation 0.23
Placebo	Worst Daily Pain	Day 14 (n=129, 125, 130)	2.5 Units on a scale	Standard Deviation 0.19
Placebo	Worst Daily Pain	Discharge (n=140, 143, 138)	4.2 Units on a scale	Standard Deviation 0.22

Comparison: Dischargep-value: 0.7511ANOVA

Comparison: Dischargep-value: 0.6742ANOVA

Comparison: Day 7p-value: 0.3808ANOVA

Comparison: Day 7p-value: 0.7021ANOVA

Comparison: Day 14p-value: 0.0045ANOVA

Comparison: Day 14p-value: 0.7916ANOVA

Comparison: Day 28p-value: 0.3682ANOVA

Comparison: Day 28p-value: 0.1419ANOVA

Other Pre-specified

Incision Length Correlated With Worst Pain

Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.

Time frame: Day 1

Population: mITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Incision Length Correlated With Worst Pain	7.1074 Centimeter (cm)	Standard Error 0.201
Pregabalin 300 mg	Incision Length Correlated With Worst Pain	7.2324 Centimeter (cm)	Standard Error 0.1966
Placebo	Incision Length Correlated With Worst Pain	7.4437 Centimeter (cm)	Standard Error 0.1977

Comparison: 24 hoursp-value: 0.3506ANOVA

Other Pre-specified

Neuropathic Pain Symptom Inventory (NPSI)

Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

Time frame: Discharge (day 3 up to day 7 PS)

Population: mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Pregabalin 150mg	Neuropathic Pain Symptom Inventory (NPSI)	Total subscale(n=132, 131, 136)	0.073 Units on a scale	Standard Error 0.0057
Pregabalin 150mg	Neuropathic Pain Symptom Inventory (NPSI)	Burning Spontaneous subscale (n=139, 145, 143)	1.86 Units on a scale	Standard Error 0.235
Pregabalin 150mg	Neuropathic Pain Symptom Inventory (NPSI)	Pressing Spontaneous subscale (n=139, 145, 143)	1.74 Units on a scale	Standard Error 0.166
Pregabalin 150mg	Neuropathic Pain Symptom Inventory (NPSI)	Paroxysmal pain subscale (n=138, 140, 143)	1.08 Units on a scale	Standard Error 0.155
Pregabalin 150mg	Neuropathic Pain Symptom Inventory (NPSI)	Evoked Pain subscale (n=134, 135, 142)	2.14 Units on a scale	Standard Error 0.177
Pregabalin 150mg	Neuropathic Pain Symptom Inventory (NPSI)	Paresthesia/dysesthesia (n=136, 140, 141)	0.46 Units on a scale	Standard Error 0.129
Pregabalin 300 mg	Neuropathic Pain Symptom Inventory (NPSI)	Paresthesia/dysesthesia (n=136, 140, 141)	0.67 Units on a scale	Standard Error 0.127
Pregabalin 300 mg	Neuropathic Pain Symptom Inventory (NPSI)	Total subscale(n=132, 131, 136)	0.070 Units on a scale	Standard Error 0.0057
Pregabalin 300 mg	Neuropathic Pain Symptom Inventory (NPSI)	Paroxysmal pain subscale (n=138, 140, 143)	0.95 Units on a scale	Standard Error 0.154
Pregabalin 300 mg	Neuropathic Pain Symptom Inventory (NPSI)	Evoked Pain subscale (n=134, 135, 142)	2.27 Units on a scale	Standard Error 0.177
Pregabalin 300 mg	Neuropathic Pain Symptom Inventory (NPSI)	Burning Spontaneous subscale (n=139, 145, 143)	1.80 Units on a scale	Standard Error 0.231
Pregabalin 300 mg	Neuropathic Pain Symptom Inventory (NPSI)	Pressing Spontaneous subscale (n=139, 145, 143)	1.60 Units on a scale	Standard Error 0.164
Placebo	Neuropathic Pain Symptom Inventory (NPSI)	Burning Spontaneous subscale (n=139, 145, 143)	1.75 Units on a scale	Standard Error 0.235
Placebo	Neuropathic Pain Symptom Inventory (NPSI)	Pressing Spontaneous subscale (n=139, 145, 143)	1.57 Units on a scale	Standard Error 0.168
Placebo	Neuropathic Pain Symptom Inventory (NPSI)	Paresthesia/dysesthesia (n=136, 140, 141)	0.91 Units on a scale	Standard Error 0.128
Placebo	Neuropathic Pain Symptom Inventory (NPSI)	Paroxysmal pain subscale (n=138, 140, 143)	1.18 Units on a scale	Standard Error 0.156
Placebo	Neuropathic Pain Symptom Inventory (NPSI)	Total subscale(n=132, 131, 136)	0.076 Units on a scale	Standard Error 0.0058
Placebo	Neuropathic Pain Symptom Inventory (NPSI)	Evoked Pain subscale (n=134, 135, 142)	2.27 Units on a scale	Standard Error 0.175

Comparison: Total subscalep-value: 0.6211ANOVA

Comparison: Total subscalep-value: 0.3687ANOVA

Comparison: Burning Spontaneous subscalep-value: 0.7078ANOVA

Comparison: Burning Spontaneous subscalep-value: 0.8696ANOVA

Comparison: Pressing Spontaneous subscalep-value: 0.432ANOVA

Comparison: Pressing Spontaneous subscalep-value: 0.8843ANOVA

Comparison: Paroxysmal pain subscalep-value: 0.6215ANOVA

Comparison: Paroxysmal pain subscalep-value: 0.2722ANOVA

Comparison: Evoked Pain subscalep-value: 0.55ANOVA

Comparison: Evoked Pain subscalep-value: 0.9942ANOVA

Comparison: Paresthesia/dysesthesiap-value: 0.0075ANOVA

Comparison: Paresthesia/dysesthesiap-value: 0.1464ANOVA

Other Pre-specified

Percentage of Participants With Wound Healing Complications - Day 14 PS

Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.

Time frame: Day 14 PS

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Superficial Incision SSI	5.0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Deep Incision SSI	0.6 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Organ/space SSI	0.6 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Non-infectious Wound Healing	4.4 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Non-infectious Wound Healing	2.5 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Superficial Incision SSI	2.5 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Organ/space SSI	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 14 PS	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 14 PS	Non-infectious Wound Healing	0.6 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 14 PS	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 14 PS	Organ/space SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 14 PS	Superficial Incision SSI	2.4 Percentage of participants

Other Pre-specified

Percentage of Participants With Wound Healing Complications - Day 28 PS

Time frame: Day 28 PS

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Superficial Incision SSI	1.9 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Deep Incision SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Organ/space SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Non-infectious Wound Healing	2.5 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Non-infectious Wound Healing	2.5 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Superficial Incision SSI	1.9 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Organ/space SSI	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 28 PS	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 28 PS	Non-infectious Wound Healing	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 28 PS	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 28 PS	Organ/space SSI	0.6 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 28 PS	Superficial Incision SSI	1.2 Percentage of participants

Other Pre-specified

Percentage of Participants With Wound Healing Complications - Day 7 PS

Time frame: Day 7 PS

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Superficial Incision SSI	1.9 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Deep Incision SSI	0.6 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Organ/space SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Non-infectious Wound Healing	3.8 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Non-infectious Wound Healing	1.9 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Superficial Incision SSI	2.5 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Organ/space SSI	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Day 7 PS	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 7 PS	Non-infectious Wound Healing	0.6 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 7 PS	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 7 PS	Organ/space SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Day 7 PS	Superficial Incision SSI	0.6 Percentage of participants

Other Pre-specified

Percentage of Participants With Wound Healing Complications - Discharge

Time frame: Discharge (day 3 up to day 7 PS)

Population: Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included.

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Discharge	Superficial Incision SSI	3.1 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Discharge	Deep Incision SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Discharge	Organ/space SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - Discharge	Non-infectious Wound Healing	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Discharge	Non-infectious Wound Healing	1.2 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Discharge	Superficial Incision SSI	1.2 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Discharge	Organ/space SSI	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - Discharge	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Discharge	Non-infectious Wound Healing	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Discharge	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Discharge	Organ/space SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - Discharge	Superficial Incision SSI	0.6 Percentage of participants

Other Pre-specified

Percentage of Participants With Wound Healing Complications - End of Treatment

Time frame: Day 1 up to Day 28 PS

Population: Safety population

Arm	Measure	Group	Value (NUMBER)
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Superficial Incision SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Deep Incision SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Organ/space SSI	0 Percentage of participants
Pregabalin 150mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Non-infectious Wound Healing	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Non-infectious Wound Healing	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Superficial Incision SSI	1.2 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Organ/space SSI	0 Percentage of participants
Pregabalin 300 mg	Percentage of Participants With Wound Healing Complications - End of Treatment	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - End of Treatment	Non-infectious Wound Healing	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - End of Treatment	Deep Incision SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - End of Treatment	Organ/space SSI	0 Percentage of participants
Placebo	Percentage of Participants With Wound Healing Complications - End of Treatment	Superficial Incision SSI	0 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)

Anxiety Before and After Surgery

Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay

Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test

Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting

Average Daily Pain

Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores

Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores

Current Pain at Rest

Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test

Current Pain - Pain With Movement Caused by Sitting

Incidence of Chronic Post-operative Pain

Integrated Analgesic Score

Non-opioid Rescue Medication - Ibuprofen

Non-opioid Rescue Medication - Paracetamol

Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication

Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication

Participant Satisfaction With Study Medication - Day 14 PS

Participant Satisfaction With Study Medication - Day 1 PS

Participant Satisfaction With Study Medication - Day 28 PS

Participant Satisfaction With Study Medication - Day 2 PS

Participant Satisfaction With Study Medication - Day 3 PS

Participant Satisfaction With Study Medication - Day 4 PS

Participant Satisfaction With Study Medication - Day 5 PS

Participant Satisfaction With Study Medication - Day 7 PS

Participant Satisfaction With Study Medication - Discharge

Participant Satisfaction With Study Medication - Surgery Day

Percent Change From Baseline in Peak Expiratory Flow

Quality of Life Using EuroQol (EQ-5D) Health State Profile

Sleep Interference

Timed Up-and-Go (TUG)

Time to Actual Discharge

Time to Meet Hospital Discharge Criteria

Total Clinically Meaningful Event (CME) Score

Total Cumulative Dose of Opioids Following Surgery

Worst Daily Pain

Incision Length Correlated With Worst Pain

Neuropathic Pain Symptom Inventory (NPSI)

Percentage of Participants With Wound Healing Complications - Day 14 PS

Percentage of Participants With Wound Healing Complications - Day 28 PS

Percentage of Participants With Wound Healing Complications - Day 7 PS

Percentage of Participants With Wound Healing Complications - Discharge

Percentage of Participants With Wound Healing Complications - End of Treatment