Pain Control With Total Knee Replacement

Study Overview
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Brief Summary
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The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.

Detailed Description
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Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.

Official Title
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Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age > 25 years old Primary osteoarthritis of the knee Must be undergoing unilateral total knee arthroplasty Anesthesia assesment score I, II, or III Exclusion Criteria: Severe joint malalignment (defined as varus/valgus angle > 20 deg) Use of gabapentin pre-operatively History of chronic pain (currently under treatment) History of substance abuse Impaired kidney function (defined as creatinine > 1.5) Epilepsy (currently on medication for treatment) Known allergy to Gabapentin Known history of depression or suicidal thoughts and behaviors Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin<br>Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. | Drug: Gabapentin<br>* Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.<br>* Other names: Neurontin;|
| Placebo Comparator: Placebo<br>Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days | Drug: Gabapentin<br>* Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.<br>* Other names: Neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Pain Scores | Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2. Scale range: 0-100 Higher Values = More Pain | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotics Consumption | Narcotics consumption was recorded on postoperative days 0, 1, and 2. | 3 days | 
| Knee Range of Motion | Patient knee range of motion was assessed on postoperative days 0, 1 and 2. | 3 days | 
| Patient Restfulness | Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2. | 3 days |