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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Mastectomy; Lymphedema
• Intervention / Treatment: 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)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: UCCC Clinical Trials Office; Phone Number: 513-584-7698; Email: cancer@uchealth.com
• Study Contact Backup: Name: Alicia Heelan, MD

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Medical Center
      • Contact: Alicia Heelan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients undergoing only a partial mastectomy or tissue-based reconstruction.
• Non-English speaking.
• Patients who are pregnant.
• Patients with an allergy to local anesthetics
• Except: patients with allergies only to topical anesthetics may be included.
• Patients with a preoperative acute or chronic pain disorder with an opioid prescription that has been prescribed within 30 days of surgery. Patients who have not filled such a prescription or who state they have not taken the medications prescribed, may be eligible on a case-by-case basis per investigator judgement.
• Patients with a history of opioid use disorder.
• Inability to provide informed consent.
• Patients who otherwise in the opinion of the Investigator are not good candidates for participation (e.g., deemed unreliable for follow-up).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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 a scale of 0-10 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. A score of 1 is the minimum while a score of 10 is the maximum. The higher the score, the more pain the patient is reporting.	21 days Post Operation

Collaborators and Investigators

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Breast Neoplasms; Lymphedema; Organic Chemicals; Surgical Procedures, Operative; Transplantation; Anilides; Amides; Aniline Compounds; Amines; Ethylamines; Tissue and Organ Harvesting; Bupivacaine; Phenoxybenzamine; Operative Blood Salvage
• Other Study ID Numbers: UCCC-BRE-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No