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

NCT03853694 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2022-07-18

Study results available
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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.

Conditions

  • Elective Cesarean Section
  • Pain Management

Interventions

DRUG

50 mcg Duramorph+ EXPAREL + multi-modal pain regimen

Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.

DRUG

150 mcg Duramorph + multi-modal pain regimen

Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.

DRUG

Exparel TAP + multi-modal pain regimen

EXPAREL administered via TAP infiltration + multi-modal pain regimen.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Nayana Nagaraj, MD, PhD, MPH · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2020-01-09
Completion
2020-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853694 on ClinicalTrials.gov