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NCT02415309 · ClinicalTrials.gov registry record · Phase 3
Premedication With Melatonin in Lumbar Medial Branch Block Procedure
A Phase 3 study, sponsored by United States Naval Medical Center, San Diego.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
NCT02415309: Completed Phase 3 study, sponsored by United States Naval Medical Center, San Diego.
NCT02415309 is a Phase 3 study that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415309, a Phase 3 study, has completed, sponsored by United States Naval Medical Center, San Diego.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
Study Summary
Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated chronic low back pain. This interventional pain procedure often occurs in the fluoroscopy suite. During this procedure, a physician inserts the needles to deliver local anesthetics such as lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint. Many patients experience anxiety before and during the lumbar medial branch block procedure and require intravenous midazolam or fentanyl for sedation. Intravenous or conscious sedation requires one-to-one nursing care, monitoring, and recovery. In order to minimize the costs and time requirements of intravenous sedation, a suitable oral medication which is readily available and non-controlled would be ideal. Several randomized double-blinded, controlled trials have investigated the anxiolytic effects of melatonin before a surgery; however no studies to date have studied the anxiolytic effects of melatonin before less invasive interventional pain procedures. This study is designed to evaluate the efficacy of melatonin for reducing anxiety in patients undergoing a lumbar medial branch block procedure. The study is a randomized, double-blinded, placebo-controlled trial with 40 patients in each group: 2 mg melatonin, 10 mg melatonin and placebo. The primary outcome is anxiety reduction in patients before undergoing the procedure. The primary outcome is measured by visual numerical rating scale for anxiety and the Amsterdam Preoperative Anxiety and Information Scale. Based on the results of previous studies, the investigators hypothesize that melatonin may reduce anxiety in patients undergoing the procedure and be a suitable alternative to intravenous sedation in the pain clinic for patients undergoing lumbar medial branch blocks.
Primary Outcome
Comparing melatonin and placebo to see if differing levels of melatonin helps prevent or alleviate anxiety in service members undergoing an interventional pain procedure. For patients participating in the LMBB, anxiety level scores will be compared among the three time-points. Primary analysis will compare the two treatment groups versus placebo. The goal of this study is to demonstrate whether melatonin has anxiolytic effects preoperatively.
Interventions
- OTHER Placebo
- DRUG 2 mg Melatonin
- DRUG 10mg Melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-07 |
| Est. Completion | 2022-05 |
| Phase | Phase 3 |
What the finished NCT02415309 record still lists
NCT02415309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02415309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415309 about?
NCT02415309 is a clinical study titled "Premedication With Melatonin in Lumbar Medial Branch Block Procedure". Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated chronic low back pain. This interventional pain procedure often occurs in the fluoroscopy suite. During this procedure, a physician inserts the needles to deliver local anesthetics such as lidocaine or bupivacaine ...
What is the current status of trial NCT02415309?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2016-07. Estimated completion is 2022-05.
What interventions are being tested in trial NCT02415309?
The interventions under investigation include: Placebo (OTHER), 2 mg Melatonin (DRUG), 10mg Melatonin (DRUG).
Who is sponsoring clinical trial NCT02415309?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415309's enrollment target sits among peer trials
25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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