Official Title: “Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Knee or Hip Arthroplasty”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • 600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
• Other: Placebo
  • Half the patients will be randomized to placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin
  • 600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.
• Placebo Comparator: Placebo

Primary Measures

• To determine if gabapentin given preoperatively and continued for three days postoperatively will reduce postoperative morphine consumption
  • Time Frame: End of study
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: End of study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hamilton Health Sciences

Overall Clinical Trial Officials and Contacts

Manyat Nantha-Aree, MD Principal Investigator Hamilton Health Sciences  

Overall Contact: Manyat Nantha-Aree, MD 905-521-2100 nantham@mcmaster.ca

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00889148

Study ID Number: 07-215

ClinicalTrials.gov Identifier: NCT00889148

Health Authority: Canada: Ethics Review Committee