Status:
COMPLETED
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Surgery
Analgesia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 p...
Eligibility Criteria
Inclusion
- Individuals ≥ 18 years of age
- Planned laparotomy by the gynecologic oncology service at the sponsor institution.
Exclusion
- 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04117074
Start Date
April 14 2021
End Date
March 17 2025
Last Update
April 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287