Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study (MOBILE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty|
- Amount of morphine consumption [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: Two years ] [ Designated as safety issue: No ]Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness
- Pain scores [ Time Frame: Two years ] [ Designated as safety issue: No ]Pain score at rest in PACU, POD1, POD2, POD3 Pain score upon passive movement in PACU, POD1, POD2, POD3 Pain score with weighbearing on POD1, POD2, POD3
|Study Start Date:||October 2007|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.
600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
Other Name: Neurontin
|Placebo Comparator: Placebo||
Half the patients will be randomized to placebo
Other Name: Sugar pill
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.
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Manyat Nantha-Aree, MD||Hamilton Health Sciences Corporation|