Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 4

Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section

NCT03853694 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 167 participants
Start Date 2019-03-04
Est. Completion 2020-01-16
Phase Phase 4

Sponsor

Pacira Pharmaceuticals

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03853694

The ClinicalTrials.gov registry entry for NCT03853694 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03853694 reports 18 study locations spanning 13 distinct geographic areas — top geographies include Florida, Massachusetts, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03853694?

This trial is sponsored by Pacira Pharmaceuticals, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial