This phase IV trial compares the effects of different injection sites for standard nerve blocks given before double mastectomy with immediate reconstruction. Nerve blocks help with pain relief during surgery and recovery, and they can be given in different areas of the body, including the upper back and/or upper chest area. While nerve blocks are standard of care for this type of surgery, it is not known which nerve block approach helps relieve pain after surgery the most. This trial studies whether one site or a combination of sites is better than the others at decreasing pain during surgery and reducing the need for pain medication after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04016376.
PRIMARY OBJECTIVE:
I. To determine the most optimal preoperative nerve block between a combination of nerve blocks (paravertebral blocks [PVB]+ pectoralis [PECS]-1 or serratus + PECS-1) compared to the use of PVB alone to decrease postoperative opioid consumption.
SECONDARY OBJECTIVES:
I. To compare intraoperative fentanyl consumption, postoperative pain scores, and chronic pain scores (up to 6 months post-surgery) in patients undergoing bilateral mastectomy with immediate reconstruction (BMw/IR) who preoperatively received a combination of nerve blocks compared to patients who received a PVB alone.
II. To compare the rates of rescue antiemetic medication use in the post-anesthesia care unit (PACU) in patients undergoing BMw/IR with a nerve block.
III. To determine quality of recovery (as determined by standard of care quality of recovery assessment, recovery tracker questionnaire, time to ambulation, ambulation distance, and physical therapy outcomes) in patients undergoing BMw/IR who preoperatively received a combination of nerve blocks compared to patients who received a PVB alone.
IV. To assess adverse surgical outcomes (defined as: transfer to the main hospital, reoperation, readmission, or urgent care visit) within the first 30 days post-surgery.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive a PVB consisting of ropivacaine (or bupivacaine), clonidine and dexamethasone via injection per standard of care.
ARM II: Patients receive a serratus and PECS-1 nerve block consisting of ropivacaine (or bupivacaine), clonidine and dexamethasone via injection per standard of care.
ARM III: Patients receive a PVB via injection as in Arm I and PECS-1 nerve block via injection as in Arm II.
All patients undergo bilateral mastectomy with immediate reconstruction.
After completion of study, patients are followed up at 30 days and between 85-100 days.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorHanae Tokita
