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Clinical trial

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

ID
Name
L12-078
Description
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.
Trial arms
Trial start
2012-09-01
Estimated PCD
2016-02-01
Trial end
2016-02-01
Status
Completed
Phase
Early phase I
Treatment
Gabapentin
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Arms:
Gabapentin, Placebo
Other names:
Fanatrex, Gabarone, Gralise, Horizant, Neurontin
Size
50
Primary endpoint
Patient Pain Scores
3 days
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-01-31

1 organization

1 product

1 indication

Organization
Texas Tech University Health Sciences Center
Product
Gabapentin
Indication
Postoperative Pain