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COMPLETED
NCT04117074
PHASE3

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

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2021-04-14

Completion Date

2025-03-17

Last Updated

2026-05-19

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States