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NCT03334903 · ClinicalTrials.gov registry record · Phase 4
Gabapentin Regimens and Their Effects on Opioid Consumption
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 77
- Enrollment target
NCT03334903 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 77 participants.
The verdict
NCT03334903, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 77 participants
- Enrollment target
Study 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.
Interventions
- DRUG Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03334903
The ClinicalTrials.gov registry entry for NCT03334903 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gabapentin is the first listed.
NCT03334903 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03334903 about?
NCT03334903 is a clinical study titled "Gabapentin Regimens and Their Effects on Opioid Consumption". 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...
What is the current status of trial NCT03334903?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 77 participants. The study started on 2018-05-15. Estimated completion is 2019-04-24.
What interventions are being tested in trial NCT03334903?
The interventions under investigation include: Gabapentin (DRUG).
Who is sponsoring clinical trial NCT03334903?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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