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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

Page last updated: October 19, 2009

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