CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 186 enrolled
Drug / intervention
Exparel + Bupivacaine +1 moredrug
Likely dose
Not stated in 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/NCT03176459
NCT03176459Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) Versus Bupivacaine Alone in Subjects Undergoing Elective Cesarean Section

Pacira Pharmaceuticals, Inc·interventional·Posted Jun 5, 2017·Updated Jan 6, 2021

In Brief

A Phase 4 clinical trial evaluating Exparel + Bupivacaine and Bupivacaine for C-Section and Pain Management. Completed, enrolled 186 participants across 12 sites.

Detailed 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.

Study Details

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

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 5, 2017
Enrollment StartJun 1, 2017
Primary CompletionNov 20, 2018
Study CompletionDec 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.1 years ago

Interventions

Exparel + Bupivacainedrug

EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.

Bupivacainedrug

Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.