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NCT03853694 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
A Phase 4 study of Pain Management and Elective Cesarean Section, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 167
- Enrollment target
- 18
- Study locations
NCT03853694: Completed Phase 4 study of Pain Management and Elective Cesarean Section, sponsored by Pacira Pharmaceuticals.
NCT03853694 is a Phase 4 study of Pain Management and Elective Cesarean Section that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 167 participants, above the 149-participant average among 31 other Pain Management trials with a reported enrollment target (12% higher). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03853694, a Phase 4 study of Pain Management and Elective Cesarean Section, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 167 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to compare total opioid consumption by subjects in different treatment groups. Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.
Primary Outcome
To Compare total opioid consumption through 72 hours following EXPAREL infiltration into the Transversus abdominus plane (TAP) with SOC in subjects undergoing an elective C-section
Conditions Studied
Interventions
- DRUG 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen
- DRUG 150 mcg Duramorph + multi-modal pain regimen
- DRUG Exparel TAP + multi-modal pain regimen
Study Locations (18)
Florida
- University of Florida- Gainesville - Gainesville
- University of Florida college of Medicine - Jacksonville - Jacksonville
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
New Jersey
- Robert Wood Johnson Medical School - New Brunswick
- St. Peter's University Medical Center - New Brunswick
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Pennsylvania
- Thomas Jefferson Medical Center - Philadelphia
- Magee-Women's Hospital of UPMC - Pittsburgh
California
- Stanford University School of Medicine - Stanford
Idaho
- Clinical Research Prime - Idaho Falls
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2019-03-04 |
| Est. Completion | 2020-01-16 |
| Phase | Phase 4 |
What the finished NCT03853694 record still lists
NCT03853694 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, above the 149-participant average among 31 other Pain Management trials with a reported enrollment target (12% higher).
The record links to 2 conditions, with Pain Management appearing as the primary indexed condition, and to 3 interventions - of which 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen is the first listed.
NCT03853694 lists 18 locations in 13 states (Florida, Massachusetts, New Jersey).
Frequently Asked Questions
What is clinical trial NCT03853694 about?
NCT03853694 is a clinical study titled "Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section". The purpose of this study is to compare total opioid consumption by subjects in different treatment groups. Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.
What is the current status of trial NCT03853694?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 167 participants. The study started on 2019-03-04. Estimated completion is 2020-01-16.
What conditions does trial NCT03853694 study?
This clinical trial studies the following conditions: Pain Management, Elective Cesarean Section.
What interventions are being tested in trial NCT03853694?
The interventions under investigation include: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen (DRUG), 150 mcg Duramorph + multi-modal pain regimen (DRUG), Exparel TAP + multi-modal pain regimen (DRUG).
Who is sponsoring clinical trial NCT03853694?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03853694 being conducted?
This trial has 18 study locations across California, Florida, Idaho, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03853694's enrollment target sits among peer trials
167 11th of 31 higher than 20 of 31 other Pain Management trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain Management 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.
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