Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment

Study Overview
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Brief Summary
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Total knee 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 int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.

Detailed Description
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The study was submitted to Health Canada and received the letter of no objection. A randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared and will be done by the pharmacy department at McMaster University. Ninety patients undergoing primary knee 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 to a placebo group.

Official Title
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Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty

Conditions
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Post Operative Pain, Total Knee Replacement

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants aged 19-90 elective single joint, primary total knee arthroplasty use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist Exclusion Criteria: bilateral total knee arthroplasty revision knee arthroplasty underlying disease 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 participant 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>Gabapentin 600 mg will be given per oral two hours preoperatively and 200 mg three times daily after surgery (600 mg/day). | Drug: Gabapentin<br>* 600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days<br>* Other names: Neurontin;|
| Placebo Comparator: Placebo<br>Placebo will match the the gabapentin pill and will be given orally. | Drug: Placebo<br>* Placebo will match the the gabapentin pill and will be given orally.<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 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness | 2 years | 

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