Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 65 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03927911
The ClinicalTrials.gov registry entry for NCT03927911 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03927911 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.