Pain Control With Total Knee Replacement

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-02-29

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.

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gabapentin

Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.

Placebo

Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days

Group Type PLACEBO_COMPARATOR

Gabapentin

Intervention Type DRUG

Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.

Interventions

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Gabapentin

Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.

Intervention Type DRUG

Other Intervention Names

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Fanatrex Gabarone Gralise Horizant Neurontin

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes