Back to resultsTrial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Primary Purpose
Postoperative Pain, Opioid Use
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesia physical status class I & II
- Age > 18 years
- English-speaking
- Capability to operate a patient-controlled analgesia (PCA) device
Exclusion Criteria:
- Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents)
- Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- History of a seizure disorder
- Current therapy with pregabalin, gabapentin, or any opioid
- Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
- CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
Sites / Locations
- IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Pregabalin 75 mg
Pregabalin 150 mg
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00781131
Brief Title
Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Official Title
A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
Pregabalin 75 mg
Arm Title
3
Arm Type
Experimental
Arm Description
Pregabalin 150 mg
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
pregabalin 75 or 150 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
lactulose placebo
Primary Outcome Measure Information:
Title
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?
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesia physical status class I & II
Age > 18 years
English-speaking
Capability to operate a patient-controlled analgesia (PCA) device
Exclusion Criteria:
Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents)
Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
History of a seizure disorder
Current therapy with pregabalin, gabapentin, or any opioid
Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B George, MD FRCPC
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24668315
Citation
George RB, McKeen DM, Andreou P, Habib AS. A randomized placebo-controlled trial of two doses of pregabalin for postoperative analgesia in patients undergoing abdominal hysterectomy. Can J Anaesth. 2014 Jun;61(6):551-7. doi: 10.1007/s12630-014-0147-4. Epub 2014 Mar 26.
Results Reference
derived
Learn more about this trial
Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
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