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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin (Lyrica)
pregabalin (Lyrica)
matched placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring pain after hysterectomy, amount of opioids used

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Non-opioid Rescue Medication - Paracetamol
The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.
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
Non-opioid Rescue Medication - Ibuprofen
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
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)
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.
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.
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.
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.
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.
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.
Participant Satisfaction With Study Medication - Surgery Day
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
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
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
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
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
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
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
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
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 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
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
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.
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 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 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.
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.
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.

Full Information

First Posted
May 1, 2007
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00468845
Brief Title
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pain after hysterectomy, amount of opioids used

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
501 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin (Lyrica)
Intervention Description
150 mg/day double blind (divided doses)
Intervention Type
Drug
Intervention Name(s)
pregabalin (Lyrica)
Intervention Description
300 mg/day double blind (divided doses)
Intervention Type
Drug
Intervention Name(s)
matched placebo
Intervention Description
matched placebo
Primary Outcome Measure Information:
Title
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Description
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])
Secondary Outcome Measure Information:
Title
Current Pain - Pain With Movement Caused by Sitting
Description
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
Title
Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test
Description
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
Title
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting
Description
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
Title
Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test
Description
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
Title
Current Pain at Rest
Description
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
Title
Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay
Description
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
Title
Total Cumulative Dose of Opioids Following Surgery
Description
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)
Title
Integrated Analgesic Score
Description
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
Title
Non-opioid Rescue Medication - Paracetamol
Description
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,
Title
Anxiety Before and After Surgery
Description
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)
Title
Non-opioid Rescue Medication - Ibuprofen
Description
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
Title
Percent Change From Baseline in Peak Expiratory Flow
Description
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)
Title
Timed Up-and-Go (TUG)
Description
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)
Title
Average Daily Pain
Description
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
Title
Worst Daily Pain
Description
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
Title
Sleep Interference
Description
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
Title
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores
Description
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
Title
Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
Description
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
Title
Participant Satisfaction With Study Medication - Surgery Day
Description
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 1
Title
Participant Satisfaction With Study Medication - Day 1 PS
Description
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 1 PS
Title
Participant Satisfaction With Study Medication - Day 2 PS
Description
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 2 PS
Title
Participant Satisfaction With Study Medication - Day 3 PS
Description
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 3 PS
Title
Participant Satisfaction With Study Medication - Day 4 PS
Description
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 4 PS
Title
Participant Satisfaction With Study Medication - Day 5 PS
Description
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 5 PS
Title
Participant Satisfaction With Study Medication - Discharge
Description
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
Discharge (day 3 up to day 7 PS)
Title
Participant Satisfaction With Study Medication - Day 7 PS
Description
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 7 PS
Title
Participant Satisfaction With Study Medication - Day 14 PS
Description
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
Title
Participant Satisfaction With Study Medication - Day 28 PS
Description
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 28 PS
Title
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Description
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
Title
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Description
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
Title
Quality of Life Using EuroQol (EQ-5D) Health State Profile
Description
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
Title
Time to Meet Hospital Discharge Criteria
Description
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
Title
Time to Actual Discharge
Description
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
Title
Incidence of Chronic Post-operative Pain
Description
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
Title
Total Clinically Meaningful Event (CME) Score
Description
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
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Wound Healing Complications - Discharge
Description
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
Discharge (day 3 up to day 7 PS)
Title
Percentage of Participants With Wound Healing Complications - Day 7 PS
Description
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 7 PS
Title
Percentage of Participants With Wound Healing Complications - Day 14 PS
Description
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
Title
Percentage of Participants With Wound Healing Complications - Day 28 PS
Description
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 28 PS
Title
Percentage of Participants With Wound Healing Complications - End of Treatment
Description
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 1 up to Day 28 PS
Title
Incision Length Correlated With Worst Pain
Description
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
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1096
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Kowloon
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1752
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Newcastle
State/Province
KwaZulu Natal
ZIP/Postal Code
2940
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Ladysmith
State/Province
KZN
ZIP/Postal Code
3370
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L8 7SS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Livingstone
ZIP/Postal Code
EH54 6PP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25565885
Citation
Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081153&StudyName=Study%20Of%20The%20Efficacy%20And%20Safety%20Of%20Pregabalin%20Compared%20To%20Placebo%20For%20Treatment%20Of%20Post-Surgical%20Pain%20From%20Hysterectomy
Description
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Learn more about this trial

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

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