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Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
Liposomal bupivacaine
Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.
Thoracic epidural analgesia (bupivacaine)
Perioperative bupivacaine based thoracic epidural placed preoperatively.
Locations (1)
Johns Hopkins Hospital
Baltimore, Maryland, United States