L12-078Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.
Gabapentin
+ Gabapentin
Neurologic Manifestations+4
+ Pain
+ Pathologic Processes
Treatment Study
Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 25 to 89 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
TTUHSC Orthopaedic Surgery MS 9436
Lubbock, United StatesOpen TTUHSC Orthopaedic Surgery MS 9436 in Google Maps