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NCT03015961 · ClinicalTrials.gov registry record · Phase 4
Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery
A Phase 4 study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT03015961: Clinical Trial Phase 4 study, sponsored by Pacira Pharmaceuticals.
NCT03015961 is a Phase 4 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03015961, a Phase 4 study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery. Secondary Objectives: The secondary objectives of this study are to compare additional efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.
Primary Outcome
AUC of VAS pain intensity scores from 0 to 72 hours postsurgery. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now." AUC curve is derived using the trapezoidal rule (see formula below) on the pain scores. AUC start with the
Interventions
- DRUG Bupivacaine HCl
- DRUG EXPAREL and bupivacaine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2017-10-30 |
| Phase | Phase 4 |
Why NCT03015961 stopped before completion
NCT03015961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine HCl is the first listed.
NCT03015961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03015961 about?
NCT03015961 is a clinical study titled "Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery". Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery. Secondary O...
What is the current status of trial NCT03015961?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2017-02-21. Estimated completion is 2017-10-30.
What interventions are being tested in trial NCT03015961?
The interventions under investigation include: Bupivacaine HCl (DRUG), EXPAREL and bupivacaine HCl (DRUG).
Who is sponsoring clinical trial NCT03015961?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03015961's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 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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