NCT06574022

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

Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Standard of care intervention is preoperative PECS-II blocks versus Intraoperative Pectoral Blocks. The medication used are standard of care and include Bupivacaine and liposomal bupivacaine. Bupivacaine is FDA approved and indicated for the local or regional anesthesia or analgesia for surgery procedures and therapeutic procedures. Liposomal bupivacaine is FDA approved and indicated for adults to produce postsurgical local analgesia and as nerve block to produce postsurgical regional analgesia.

Conditions

• Mastectomy; Lymphedema
• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-25
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-08-27
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study