Status:
COMPLETED
Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Lead Sponsor:
IWK Health Centre
Conditions:
Postoperative Pain
Eligibility:
FEMALE
Up to 65 years
Phase:
PHASE4
Brief Summary
We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality ...
Eligibility Criteria
Inclusion
- American Society of Anesthesia physical status class I \& II
- Age ¬\< 65 years
- English-speaking
- Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)
Exclusion
- Known or suspected allergy, sensitivity, or contraindication to pregabalin
- Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
- Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- History of a seizure disorder
- Pregnancy
- Current pre-operative therapy with pregabalin, gabapentin, or any opioid
- Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative 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 :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00785382
Start Date
January 1 2009
End Date
December 1 2011
Last Update
October 31 2012
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8