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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Total Hip Replacement

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days. | Drug: Gabapentin<br>* 600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days<br>* Other names: Neurontin;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Half the patients will be randomized to placebo<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of morphine consumption |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness | Two years | 
| Pain scores | 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 | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, arthroplasty, postoperative pain, gabapentin