Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
Completed · Phase 3
Conditions studied: Surgery, Analgesia
In brief
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.
Key facts
- Study ID
- NCT04117074
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 106
- Starts
- 2021-04-14
- Expected to finish
- 2025-03-17
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Individuals ≥ 18 years of age
- Planned laparotomy by the gynecologic oncology service at the sponsor institution.
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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