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

J17157

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.

2021-04-14

2024-09-01

2025-09-01

Recruiting

Early phase I

100

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-06-18