This phase I trial studies how well bupivacaine hydrochloride or liposomal bupivacaine with or without redosing works in reducing pain after surgery in patients undergoing gynecologic surgery. Bupivacaine hydrochloride and liposomal bupivacaine are forms of anesthesia administered under the abdominal muscles called a transversus abdominis plane (TAP) block. Giving bupivacaine hydrochloride or liposomal bupivacaine TAP blocks may lower pain following open abdominal surgery. This study may also help doctors learn more about which type of TAP block works better at controlling pain and preventing side effects after surgery, and whether TAP blocks will decrease narcotic medication use.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04849858.
PRIMARY OBJECTIVES:
I. To determine if liposomal bupivacaine (LB) TAP block will lead to superior pain control following abdominopelvic surgery via midline vertical incision in gynecologic oncology patients.
II. To determine if re-dosing LB via TAP block will lead to superior pain control compared to a single peri-operative dose.
III. To determine if LB will reduce length of hospital stay and opioid-related post-operative complications.
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP I: Patients receive bupivacaine hydrochloride under the abdominal muscle (TAP block) while undergoing gynecologic surgery.
GROUP II: Patients receive liposomal bupivacaine under the abdominal muscle (TAP block) while undergoing gynecologic surgery.
GROUP III: Patients receive liposomal bupivacaine under the abdominal muscle (TAP block) while undergoing gynecologic surgery, and then receive a second dose of LB TAP block 48-60 hours after the first dose.
After completion of study, patients are followed up at 2 and 6 weeks after surgery.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorJill Tseng
