This phase III trial studies how well four quadrants transverse abdominus plane block with bupivacaine hydrochloride and liposomal bupivacaine work in treating participants undergoing specialized abdominal surgery for cancer. Four quadrants transverse abdominus plane block is a procedure that delivers anesthesia such as bupivacaine hydrochloride and liposomal bupivacaine to help relieve pain after surgery. Four quadrants transverse abdominus plane block may work better in relieving pain after cytoreductive surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03359811.
PRIMARY OBJECTIVES:
I. To evaluate the impact four quadrants transverse abdominus plane block (4Q-TAP) versus thoracic epidermal analgesia (TEA) (the routine care) on the quality of recovery and other clinically relevant outcomes after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) surgery.
II. To study the incidence of adverse events associated with 4Q-TAP versus TEA after CRS-HIPEC surgery.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (TEA): Participants receive standard of care TEA.
GROUP II (4Q-TAP BLOCK): Participants receive 4 injections of 4Q-TAP block with bupivacaine hydrochloride and liposomal bupivacaine into different parts of the abdomen after receiving general anesthesia.
After completion of the study treatment, participants are followed up at days 1-3, 5, 7, 10, and 30.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJuan P Cata
