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Gabapentin Regimens and Their Effects on Opioid Consumption

NCT03334903 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2021-02-18

Study results available
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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.

Conditions

Interventions

DRUG

Gabapentin

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Wolfgang Fitz, M.D. · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2019-04-24
Completion
2019-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03334903 on ClinicalTrials.gov