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

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Postoperative Pain; Total Hip Replacement

Treatments: Drug: Gabapentin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00889148

07-215-THR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

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

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Treatment:

Other: Placebo