NCT04117074

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgery
• Analgesia

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.
OTHER	Thoracic epidural analgesia (bupivacaine)	Perioperative bupivacaine based thoracic epidural placed preoperatively.

Timeline

• Start date: 2021-04-14
• Primary completion: 2025-03-03
• Completion: 2025-03-17
• First posted: 2019-10-07
• Last updated: 2025-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study