CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 167 enrolled
Drug / intervention
50 mcg Duramorph+ EXPAREL + multi-modal pain regimen +2 moredrug
Likely dose
50 mcg Duramorph+ EXPAREL + multi-modal pain regimenfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03853694
NCT03853694Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)

Pacira Pharmaceuticals, Inc·interventional·Posted Feb 26, 2019·Updated Jul 18, 2022

In Brief

A Phase 4 clinical trial evaluating 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen, 150 mcg Duramorph + multi-modal pain regimen, and 1 other intervention for Elective Cesarean Section and Pain Management. Completed, enrolled 167 participants across 18 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsElective Cesarean Section, Pain Management
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 26, 2019
Enrollment StartMar 4, 2019
Primary CompletionJan 9, 2020
Study CompletionJan 16, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.4 years ago

Interventions

50 mcg Duramorph+ EXPAREL + multi-modal pain regimendrug

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

150 mcg Duramorph + multi-modal pain regimendrug

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

Exparel TAP + multi-modal pain regimendrug

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