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Gabapentin Regimens and Their Effects on Opioid Consumption

CompletedPhase 4NCT03334903
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Official title
Gabapentin Regimens and Their Effects on Opioid Consumption
Interventions
Sponsor
Brigham and Women's Hospital
Start date
2018-05-15
Primary completion
2019-04-24
Sex
All
Age range
from 18 Years
Healthy volunteers
true
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * At least 18 years of age * Receiving surgery for total knee replacement (TKR) * Opioid naïve * Agrees to use tracking diary to monitor opioid consumption Exclusion Criteria: * Over 75 years of age on the date of surgery * If female, pregnant * Has received investigational articles \< 30 days prior to enrollment or is currently receiving investigational products or devices * Chronic pain syndrome * Taking chronic narcotics and/or taking more than 10 mg of codeine per day, any amount of Hydrocodone, over 200 mg of tramadol per day, or any other narcotics prescribed for moderate or severe pain * Involved in pain clinics for chronic pain, or pain that is not related to the surgical site * On long-term gabapentin regimen * Taking Lyrica or Gralise * Known history of depression or has been treated for depression with medication * Has entertained suicidal thoughts and behaviors

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03334903