drugset
drugset / Trial / NCT04117074

Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery

NCT04117074 ↗

Phase 3 Completed 106 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Pacira Pharmaceuticals, Inc · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-04-14
Primary completion
2025-03-03
Completion
2025-03-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 266 mg Other

Indications

No indication recorded.