Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
Information source: McMaster University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain; Joint Replacement
Intervention: Gabapentin (Drug); Placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Hamilton Health Sciences Official(s) and/or principal investigator(s):
Manyat Nantha-Aree, MD, Principal Investigator, Affiliation: Hamilton Health Sciences
Overall contact:
Manyat Nantha-Aree, MD, Phone: 905-521-2100, Ext: 44890, Email: nantham@mcmaster.ca
Summary
Total knee and hip arthroplasty are amongst the most painful procedures postoperatively, and
pain management can be a challenge. Different measures have been introduced to manage
severe postoperative pain in these patients. Previous studies have investigated gabapentin
in acute postoperative pain and demonstrated reduced postoperative pain, postoperative
morphine consumption, morphine related side effects, and postoperative pain scores. To date,
this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.
Clinical Details
Official title: Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Knee or Hip Arthroplasty
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To determine if gabapentin given preoperatively and continued for three days postoperatively will reduce postoperative morphine consumption
Secondary outcome: To determine if multiple doses of gabapentin decrease morphine-related side effect, improve quality of pain treatment, or patient satisfaction after total knee or hip replacement surgery.
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 and done by the pharmacy department at McMaster University. The
randomization will be stratified by type of knee arthroplasty. Ninety patients undergoing
primary total knee arthroplasty and ninety patients undergoing primary hip arthroplasty will
be recruited from the preoperative clinic. Forty-five patients in each population will be
allocated to a gabapentin group and the other forty-five patients will be allocated to a
placebo group.
Eligibility
Minimum age: 19 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- participants aged 19-90
- elective single joint, primary total knee arthroplasty or primary total hip
arthroplasty
- use of PCA with morphine for postoperative pain control has been discussed and agreed
upon between patient and anesthetist
Exclusion Criteria:
- bilateral total knee arthroplasty or bilateral total hip arthroplasty
- revision total knee or 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
Locations and Contacts
Manyat Nantha-Aree, MD, Phone: 905-521-2100, Ext: 44890, Email: nantham@mcmaster.ca
Hamilton Health Sciences, Hamilton, Ontario L8N 3Z5, Canada; Recruiting
James Paul, MD, Sub-Investigator
Additional Information
Starting date: October 2007
Ending date: February 2010
Last updated: April 27, 2009
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