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NCT03176459 · ClinicalTrials.gov registry record · Phase 4
Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections
A Phase 4 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 186
- Enrollment target
NCT03176459: Completed Phase 4 study, sponsored by Pacira Pharmaceuticals.
NCT03176459 is a Phase 4 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 186 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03176459, a Phase 4 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 186 participants
- Enrollment target
Study Summary
Primary objective: The primary objective of this study is to compare total opioid consumption through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus abdominis plane (TAP) after spinal anesthesia to active bupivacaine HCl TAP infiltration after spinal anesthesia in subjects undergoing an elective cesarean section (C-section). Secondary objective: The secondary objectives are to assess efficacy and safety parameters and patient satisfaction.
Primary Outcome
The primary endpoint is the total postsurgical opioid consumption (mg) in oral morphine equivalent dose (OMED) through 72 hours.
Interventions
- DRUG Bupivacaine
- DRUG Exparel + Bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2018-12-04 |
| Phase | Phase 4 |
What the finished NCT03176459 record still lists
NCT03176459 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine is the first listed.
NCT03176459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03176459 about?
NCT03176459 is a clinical study titled "Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections". Primary objective: The primary objective of this study is to compare total opioid consumption through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus abdominis plane (TAP) after spinal anesthesia to active bupivacaine HCl TAP infiltration after spinal anesthesia in subje...
What is the current status of trial NCT03176459?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 186 participants. The study started on 2017-06-01. Estimated completion is 2018-12-04.
What interventions are being tested in trial NCT03176459?
The interventions under investigation include: Bupivacaine (DRUG), Exparel + Bupivacaine (DRUG).
Who is sponsoring clinical trial NCT03176459?
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 NCT03176459's enrollment target sits among peer trials
186 459th of 2000 higher than 1,541 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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