Completed
PHASE3
INTERVENTIONAL
NCT04117074
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
View on ClinicalTrials.gov
Updated Dec 15, 2025
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 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.
Interventions
Name:
Liposomal bupivacaine
Type:
DRUG
Description:
Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.
Name:
Thoracic epidural analgesia (bupivacaine)
Type:
OTHER
Description:
Perioperative bupivacaine based thoracic epidural placed preoperatively.
Primary Outcomes
Measure:
Analgesia as assessed by pain intensity scores on a visual analog scale
TimeFrame:
0 to 48 hours postoperatively
Description:
Pain intensity will be measured using visual analog scale (VAS) pain intensity scores. The VAS scores pain intensity on a scale of 0-10, where 0 is no pain and 10 is the most severe pain.
Measure:
Total opioid consumption
TimeFrame:
0 to 48 hours postoperatively
Description:
Total opioid consumption in IV mg morphine equivalents from 0 to 48 hours postoperatively will be compared between the two arms.
Trial Information
NCT ID
NCT04117074
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Updated
December 15, 2025