Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
NCT Number: NCT06574022
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Mastectomy; Lymphedema|Breast Cancer
Interventions: DRUG: Bupivacain|DRUG: Exparel|PROCEDURE: Intraoperative Pecs II block (IOB) & superior AT (EX or BP)|PROCEDURE: Preoperative Pecs II block (POB) & superior AT (EX or BP)
Sponsor: University of Cincinnati
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-12-01
Locations: University of Cincinnati Medical Center, Cincinnati, Ohio, 45219, United States

Summary:
The purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

Primary Outcome Measures: Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents), Post-operative opioid usage as measured by total inpatient and outpatient opioid use (oral morphine milliequivalents) through 14 days post-op., 14 days post-operation|Postoperative pain as indicated by postoperative opioid use discontinuation, Post-operative opioid usage as measured by time to opiate discontinuation through 14 days post-op., 14 days post-operation
Secondary Outcome Measures: Post-operative pain scores indicated by patient report Numeric Rating Scale, Post-operative pain scores as measured by the Numeric Rating Scale pain scores. Maximum, minimum, and mean pain scores on each day of hospitalization, starting day of surgery., 21 days Post Operation|Post-operative pain scores indicated by patient survey, Post-operative pain scores as measured by patient survey. Patient survey completed on post-operative days 1 (while inpatient) and at their post-operative appointment (1-3 weeks post-op). The patient survey is based on the Clinically Aligned Pain Tool which is a newer tool that attempts to address some of the major limitations inherent with the much more basic numeric rating scale., 21 days Post Operation|Patient satisfaction indicated by patient report, Patient satisfaction measured at the patient's first postoperative visit (1-3 weeks post-op) using a 10-point Likert scale. The 10 Point Likert Scale will have minimum value of 1 and maximum of 10 with 1 being least satisfied (worse outcome) and 10 being most satisfied (better outcome)., 21 days Post Operation|Intraoperative procedure time measured as from time of incision to start of closing, Total intraoperative procedure time will be measured as from time of incision to start of closing if no reconstruction is performed or to time of Panel 1 completion to be followed by the reconstruction procedure by Panel 2., Day 0: Surgery|Intraoperative opioid administration measured in Milliequivalents, Intraoperative opioid administration in IV Morphine Milliequivalents., Day 0: Surgery|Operating room delays measured as anesthesia start time that is greater than 1 hour after the scheduled start time, Number of operating room delays will be measured as anesthesia start time that is greater than 1 hour after the scheduled start time., Day 0: Surgery|Postoperative length of stay as measured by the number of nights spent in the hospital after surgery., Postoperative length of stay as measured by the number of nights spent in the hospital after surgery., Day 0-7