Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study

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

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 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.

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. 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

• Amount of morphine consumption
  • Time Frame: Two years
    Safety Issue?: No

Secondary Measures

• Side effects
  • Time Frame: Two years
    Safety Issue?: No
• Pain scores
  • Time Frame: Two years
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• 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

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 Investigator: Hamilton Health Sciences Corporation Other

Overall Clinical Trial Officials and Contacts

Manyat Nantha-Aree, MD Principal Investigator Hamilton Health Sciences Corporation  

Information obtained from ClinicalTrials.gov on February 02, 2012

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

Study ID Number: 07-215-THR

ClinicalTrials.gov Identifier: NCT00889148

Health Authority: Canada: Ethics Review Committee