CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 106 enrolled
Drug / intervention
Liposomal bupivacaine +1 moredrug
Likely dose
Liposomal bupivacaine 20 mLfrom 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/NCT04117074
NCT04117074Phase 3Completed
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A Non-Inferiority Randomized Trial Comparing the Impact of Thoracic Epidural Analgesia Versus Surgical Site Infiltration With Liposomal Bupivicaine on the Postoperative Recovery of Patients Following Open Gynecologic Surgery

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Oct 7, 2019·Updated May 19, 2026

In Brief

A Phase 3 clinical trial evaluating Liposomal bupivacaine and Thoracic epidural analgesia (bupivacaine) for Surgery and Analgesia. Completed, enrolled 106 participants across 1 site.

Detailed Summary

The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery, Analgesia
CountriesUnited States
CollaboratorsPacira Pharmaceuticals, Inc

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 7, 2019
Enrollment StartApr 14, 2021
Primary CompletionMar 3, 2025
Study CompletionMar 17, 2025
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.7 years ago

Interventions

Liposomal bupivacainedrug

Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.

Thoracic epidural analgesia (bupivacaine)other

Perioperative bupivacaine based thoracic epidural placed preoperatively.