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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 is a Phase 4 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 186 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03176459
The ClinicalTrials.gov registry entry for NCT03176459 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 186 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 Bupivacaine is the first listed.
NCT03176459 reports 0 study locations.
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.
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