Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
NCT00781131 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2013-05-23
Summary
We hypothesize that pregabalin will decrease post-operative pain scores and opioid use following abdominal hysterectomy compared to placebo. This study has been designed to determine if after an abdominal hysterectomy, the addition of pregabalin to their peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in terms of lower pain scores and reduced usage of opioids. The primary outcome will be post-operative pain, measured by total opioid consumption.
Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?
Conditions
- Postoperative Pain
- Opioid Use
Interventions
- DRUG
-
Pregabalin
pregabalin 75 or 150 mg
- DRUG
-
lactulose placebo
Sponsors & Collaborators
-
IWK Health Centre
lead OTHER
Principal Investigators
-
Ronald B George, MD FRCPC · IWK Health Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2010-07-31
- Completion
- 2011-01-31
Countries
- Canada
Study Locations
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