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NCT02206685 · ClinicalTrials.gov registry record · Phase 4
A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery
A Phase 4 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
NCT02206685: Completed Phase 4 study, sponsored by Baylor College of Medicine.
NCT02206685 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 74 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02206685, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
Study Summary
Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which is a measurement used for evaluation of curves in scoliosis on an anterior-posterior radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40 degrees in the lumbar region) or when the curvature causes significant pain, or respiratory and cardiovascular restriction. Patient undergoing this surgical correction experience severe pain in the postoperative period and the management includes the use of opioid-based patient-controlled analgesia (PCA).
Primary Outcome
Subjects were given access to Patient-Controlled Intravenous Opioid Administration (PCA) to manage their post-operative pain. The doses of morphine were calculated at at PACU, 24 hours, 48 hours and 72 hours respectively.
Interventions
- DRUG Methadone
- DRUG Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2014-05 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 4 |
What the finished NCT02206685 record still lists
NCT02206685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT02206685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02206685 about?
NCT02206685 is a clinical study titled "A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery". Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which is a measurement used for evaluation of curves in scoliosis on an anterior-posterior radiographic projection of t...
What is the current status of trial NCT02206685?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2014-05. Estimated completion is 2020-01-27.
What interventions are being tested in trial NCT02206685?
The interventions under investigation include: Methadone (DRUG), Normal Saline (DRUG).
Who is sponsoring clinical trial NCT02206685?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02206685's enrollment target sits among peer trials
74 1027th of 2000 higher than 968 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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