Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Information source: IWK Health Centre
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain; Opioid Use
Intervention: Pregabalin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: IWK Health Centre Official(s) and/or principal investigator(s):
Ronald B George, MD FRCPC, Principal Investigator, Affiliation: IWK Health Centre
Overall contact:
Ronald B George, MD FRCPC, Phone: (902) 470-7059, Email: rbgeorge@dal.ca
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?
Clinical Details
Official title: A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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?
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. American Society of Anesthesia physical status class I & II
2. Age > 18 years
3. English-speaking
4. Capability to operate a patient-controlled analgesia (PCA) device
Exclusion Criteria:
1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of
the standardized medications (i. e. morphine, anesthetic agents)
2. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
3. History of a seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to
cooperate with post-operative study data collection
6. CrCl < 60 ml/min [CrCl = 0. 85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
Locations and Contacts
Ronald B George, MD FRCPC, Phone: (902) 470-7059, Email: rbgeorge@dal.ca
IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada; Recruiting
Ronald B George, MD FRCPC, Phone: (902) 470-6627, Email: rbgeorge@dal.ca
Ronald George, Phone: (902) 470-7059, Email: rbgeorge@dal.ca
Dolores McKeen, MD MSc FRCPC, Sub-Investigator
Ronald B George, MD FRCPC, Principal Investigator
Additional Information
Starting date: May 2008
Last updated: August 7, 2009
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