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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: Clinical Trial Phase 4 study, sponsored by Montefiore Medical Center.
NCT02989597 is a Phase 4 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores ar
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 |
Why NCT02989597 stopped before completion
NCT02989597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Ketamine is the first listed.
NCT02989597 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02989597's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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