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Clinical Trials/NCT01307202
NCT01307202
Completed
Not Applicable

Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty

McMaster University1 site in 1 country101 target enrollmentOctober 2007

Overview

Phase
Not Applicable
Intervention
Gabapentin
Conditions
Post Operative Pain
Sponsor
McMaster University
Enrollment
101
Locations
1
Primary Endpoint
Amount of morphine consumption
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Total knee 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 int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.

Detailed Description

The study was submitted to Health Canada and received the letter of no objection. A randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared and will be done by the pharmacy department at McMaster University. Ninety patients undergoing primary knee 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 to a placebo group.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
February 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • participants aged 19-90
  • elective single joint, primary total knee 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
  • revision knee arthroplasty
  • underlying disease 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
  • participant 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

Arms & Interventions

Gabapentin

Gabapentin 600 mg will be given per oral two hours preoperatively and 200 mg three times daily after surgery (600 mg/day).

Intervention: Gabapentin

Placebo

Placebo will match the the gabapentin pill and will be given orally.

Intervention: Placebo

Outcomes

Primary Outcomes

Amount of morphine consumption

Time Frame: 2 years

Secondary Outcomes

  • Side effects(2 years)

Study Sites (1)

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