Clinical trial NCT00889148: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Total Hip Replacement
Keywords: hip
arthroplasty
postoperative pain
gabapentin
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 103
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Amount of morphine consumption
timeFrame: Two years
Secondary outcomes:
measure: Side effects
timeFrame: Two years
measure: Pain scores
timeFrame: Two years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Manyat Nantha-Aree, MD
role: PRINCIPAL_INVESTIGATOR
References: