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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Individuals ≥ 18 years of age

• Planned laparotomy by the gynecologic oncology service at the sponsor institution.

Exclusion Criteria:

• Individuals who have a contraindication to thoracic epidural analgesia

• Individuals with a coagulation disorder

• Individuals with an infection at the site of epidural placement

• Individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions

• Individuals with spinal pathology: abnormal spine anatomy, surgical fusion, or spinal column lesions

• Individuals who have a contraindication to liposomal bupivacaine

• Individuals with a known allergic reaction to liposomal bupivacaine

• Individuals with Childs-Pugh Class B or C liver disease

• Individuals who have a history of long-term opioid use for chronic pain, defined as use of opioid pain medications for ≥4 weeks prior to surgery.