Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

August 1, 2026

Study Completion Date

December 1, 2026

Conditions
Mastectomy; LymphedemaBreast Cancer
Interventions
DRUG

Bupivacain

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 30 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

DRUG

Exparel

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle of 20 cc of Exparel mixed with 10 cc of 0.5% bupivacaine after mastectomy completion and prior to reconstruction, if performed, or wound closure.

PROCEDURE

Intraoperative Pecs II block (IOB) & superior AT (EX or BP)

Intraoperative direct visualization of the pectoralis nerves and injection using a 21-gauge needle with superior anesthetic as determined by stage I, after mastectomy completion and prior to reconstruction, if performed, or wound closure.

PROCEDURE

Preoperative Pecs II block (POB) & superior AT (EX or BP)

Preoperative Pecs II block to be administered by 1 of 6 acute pain specialized anesthesiologists in same day surgery. Patient will be lightly sedated with midazolam, at the discretion of the anesthesiologist. The pecs II block will be performed under ultrasound guidance using a 21-gauge, 80 mm length needle to administer the superior anesthetic as determined in stage I.

Trial Locations (1)

45219

University of Cincinnati Medical Center, Cincinnati

All Listed Sponsors
lead

University of Cincinnati

OTHER

NCT06574022 - Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks | Biotech Hunter | Biotech Hunter