CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 77 enrolled
Drug / intervention
Gabapentindrug
Likely dose
Gabapentin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03334903
NCT03334903Phase 4Completed

Gabapentin Regimens and Their Effects on Opioid Consumption

Brigham and Women's Hospital·interventional·Posted Nov 7, 2017·Updated Feb 18, 2021

In Brief

A Phase 4 clinical trial evaluating Gabapentin for Knee Osteoarthritis and 3 related conditions. Completed, enrolled 77 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the best strategy of administering gabapentin in connection with our current approach to perioperative pain management. We aim to evaluate two different adjunct gabapentin regimens given in the perioperative period, and to identify which manages patient pain more effectively and safely. In this evaluation, we will identify the quantity of patients' opioid consumption, the quality of their pain management, and the frequency and severity of any side effects they might experience. Patients who are undergoing total knee replacement (TKR) and choose to participate will be randomly assigned to a treatment group using computer-generated randomization. Patients in group 1 (the control group) will receive the standard of care as pertains to gabapentin. This consists of a single 600 mg dose of gabapentin administered to the patient approximately one to two hours before surgery, then a dose of 600 mg each morning during postoperative admission. Patients in Group 2 will receive 600 mg preoperatively, plus an additional postoperative gabapentin regimen: they will take 300 mg of gabapentin every 8 hours for 1 week, then a single nightly dose of 300 mg for another month.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 7, 2017
Enrollment StartMay 15, 2018
Primary CompletionApr 24, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.7 years ago

Interventions

Gabapentindrug

600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.