Status:
COMPLETED
Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Postoperative Pain
Total Hip Replacement
Eligibility:
All Genders
19-90 years
Phase:
NA
Brief Summary
Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain in th...
Detailed Description
The study was submitted to Health Canada and has received the letter of no objection. A randomized, double-blind, placebo-controlled trial will be conducted. The randomization scheme will be prepared ...
Eligibility Criteria
Inclusion
- participants aged 19-90
- elective single joint, primary total hip arthroplasty
- use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist
Exclusion
- bilateral total hip arthroplasty
- revision hip arthroplasty
- underlying diseases of epilepsy, seizure, or chronic pain syndrome
- active gastrointestinal bleeding within the last 6 months
- history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
- known or suspected history of drug or alcohol abuse
- participate currently takes gabapentin or pregabalin for any reason
- participant currently takes pain medication that is more potency than codeine or oxycodone (morphine, hydromorphone, meperidine, methadone, fentanyl, including any long acting narcotics)
- known allergy to study medications: gabapentin, morphine, NSAID, acetaminophen
- unable to tolerate morphine
- liver impairments
- kidney impairment or calculated creatinine clearance by Cockcroft-Gault formula is \<=60ml/min
- pregnancy or breast-feeding
- participant currently receives associated worker's compensation benefits (WSIB)
- participant unable or unwilling to give written or informed consent
- unable to use PCA
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00889148
Start Date
October 1 2007
End Date
February 1 2011
Last Update
March 2 2011
Active Locations (1)
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1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5