Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02989597 · ClinicalTrials.gov registry record · Phase 4
Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients
A Phase 4 study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT02989597 is a Phase 4 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT02989597, a Phase 4 study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset to withdrawal. The literature comparing methadone to more commonly used post-operative narcotics demonstrates that it manages pain better, sustains consistent plasma concentrations, decreases overall narcotic requirement, results in no additional adverse events, and is safe, even in children, across several studies. Since the standard of care is non-methadone narcotic usage to manage the significant pain of complex spinal surgery cases, it is understandable that methadone could be a desirable alternative to promote sustained pain control and early ambulation in these patients. The goal of this study is to compare the effect of a single dose of methadone administered intraoperatively in enrolled spinal fusion patients to their historical controls given fentanyl and morphine, and determine if more sustained pain control during the first few days after surgery provides a better subjective experience for the patient with less pain, which allows them to ambulate and leave the hospital sooner than patients given a standard regimen.
Interventions
- DRUG Ketamine
- DRUG Dexamethasone
- DRUG Methadone Hydrochloride
- OTHER Standard pain regimen
- PROCEDURE Spinal Fusion Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-07-29 |
| Est. Completion | 2020-11-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02989597
The ClinicalTrials.gov registry entry for NCT02989597 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ketamine is the first listed.
NCT02989597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02989597 about?
NCT02989597 is a clinical study titled "Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients". Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset...
What is the current status of trial NCT02989597?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2017-07-29. Estimated completion is 2020-11-10.
What interventions are being tested in trial NCT02989597?
The interventions under investigation include: Ketamine (DRUG), Dexamethasone (DRUG), Methadone Hydrochloride (DRUG), Standard pain regimen (OTHER), Spinal Fusion Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT02989597?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.