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NCT03927911 · ClinicalTrials.gov registry record · Phase 4
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
A Phase 4 study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
NCT03927911: Clinical Trial Phase 4 study, sponsored by Pacira Pharmaceuticals.
NCT03927911 is a Phase 4 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03927911, a Phase 4 study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
Study Summary
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen. Secondary Objectives: The secondary objectives of this study are to: 1. Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries through 72 hours, including time to first opioid and opioid-related adverse events (ORAEs). 2. Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries, including discharge readiness, hospital (or other facility) length of stay (LOS), discharge disposition, hospital readmissions, and health service utilization.
Primary Outcome
Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery
Interventions
- DRUG Standard of Care
- DRUG EXPAREL and Bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2020-08-04 |
| Phase | Phase 4 |
Why NCT03927911 stopped before completion
NCT03927911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03927911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03927911 about?
NCT03927911 is a clinical study titled "Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries". Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control ...
What is the current status of trial NCT03927911?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2019-07-31. Estimated completion is 2020-08-04.
What interventions are being tested in trial NCT03927911?
The interventions under investigation include: Standard of Care (DRUG), EXPAREL and Bupivacaine (DRUG).
Who is sponsoring clinical trial NCT03927911?
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 NCT03927911's enrollment target sits among peer trials
65 1091st of 2000 higher than 903 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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