Status:
COMPLETED
Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Lead Sponsor:
IWK Health Centre
Conditions:
Postoperative Pain
Opioid Use
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 abdom...
Eligibility Criteria
Inclusion
- American Society of Anesthesia physical status class I \& II
- Age \> 18 years
- English-speaking
- Capability to operate a patient-controlled analgesia (PCA) device
Exclusion
- 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 \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00781131
Start Date
May 1 2008
End Date
January 1 2011
Last Update
May 23 2013
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8