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Clinical Trials/NCT00889148
NCT00889148
Completed
Not Applicable

Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty

Hamilton Health Sciences Corporation1 site in 1 country103 target enrollmentOctober 2007

Overview

Phase
Not Applicable
Intervention
Gabapentin
Conditions
Postoperative Pain
Sponsor
Hamilton Health Sciences Corporation
Enrollment
103
Locations
1
Primary Endpoint
Amount of morphine consumption
Status
Completed
Last Updated
15 years ago

Overview

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 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.

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. 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.

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

Investigators

Eligibility Criteria

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

Arms & Interventions

Gabapentin

600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.

Intervention: Gabapentin

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Amount of morphine consumption

Time Frame: Two years

Secondary Outcomes

  • Side effects(Two years)
  • Pain scores(Two years)

Study Sites (1)

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