This randomized phase III trial compares blocking the abdominal nerves using an infusion of local anesthetic (using the Nimbus Ambulatory Infusion System) or a placebo (inactive treatment) before surgery in reducing pain in patients with breast cancer undergoing breast reconstruction surgery. The transversus abdominis (abdominal nerves) plane block is a procedure that targets the nerves near the surgical area and when given before surgery may improve patient comfort and reduce pain medication use after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02601027.
PRIMARY OBJECTIVES:
I. To determine if pre-operative transversus abdominis plane (TAP) blocks with continued infusion of local anesthetic post-operatively affect post-operative narcotic usage as compared to a placebo TAP block.
SECONDARY OBJECTIVES:
I. To determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect post-operative pain scores as compared to a placebo TAP block.
II. To determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect anti-emetic usage as compared to a placebo TAP block.
III. To determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to ambulation post-operatively as compared to a placebo TAP block.
IV. To determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to first bowel movement as compared to a placebo TAP block.
V. To determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect patient-reported quality of life as compared to a placebo TAP block.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo TAP block with bupivacaine hydrochloride via Nimbus Ambulatory Infusion System before surgery, every 4 hours during surgery, and then every 4 hours after surgery on day 1.
ARM II: Patients undergo TAP block with saline via Nimbus Ambulatory Infusion System before surgery, every 4 hours during surgery, and then every 4 hours after surgery on day 1.
After completion of study treatment, patients are followed up at 1-6 months.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorGordon Lee
