Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients who are 18 years of age or older
• Patients undergoing mastectomy with or without axillary surgery, with or without reconstruction surgery at UCMC for breast cancer or high-risk of breast cancer. Patients with high-risk of breast cancer are those who have atypical/precancerous breast lesion(s), genetic mutation with increased risk of cancer (e.g., BRCA1, BRCA2 etc..) and/or a strong family history of breast cancer in the opinion of the investigator.
Locations
United States
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
UCCC Clinical Trials Office
cancer@uchealth.com
513-584-7698
Backup
Alicia Heelan, MD
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 100
Treatments
Active_comparator: 1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB)
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.
Active_comparator: 2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX)
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.
Active_comparator: 3) 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.
Active_comparator: 4) 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.
Related Therapeutic Areas
Sponsors
Leads: University of Cincinnati