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

NCT06574022 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: UCCC-BRE-23-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mastectomy; Lymphedema; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Post-operative pain scores indicated by patient report Numeric Rating Scale

  21 days Post Operation

• Post-operative pain scores indicated by patient survey

  21 days Post Operation

• Patient satisfaction indicated by patient report

  21 days Post Operation

• Intraoperative procedure time measured as from time of incision to start of closing

  Day 0: Surgery

• Intraoperative opioid administration measured in Milliequivalents

  Day 0: Surgery

Study Arms (4)

1) Intraoperative Pecs Blocks (IOB) & 30 cc of 0.5% bupivacaine (PB)

ACTIVE COMPARATOR

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.

2) Intraoperative Pecs Blocks (IOB) & 20 cc of Exparel mixed w/10 cc of 0.5% bupivacaine (EX)

ACTIVE COMPARATOR

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.

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

ACTIVE COMPARATOR

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)

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

ACTIVE COMPARATOR

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.

Interventions

Bupivacain DRUG

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.

Exparel DRUG

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.

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

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.

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

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Bupivacaine; Operative Blood Salvage; Phenoxybenzamine

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Ethylamines

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698; cancer@uchealth.com

Alicia Heelan, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study Design Summary: Stage I: A randomized trial to assess the effectiveness of AT combined with IOB. Stage II: Based on Stage I results, evaluate two BTs. Enroll 40 patients per group (n1 = 40, n2 = 40) to achieve 80% power at α = 0.05, with one interim analysis after 50% enrollment. If interim results (n1 = 20, n2 = 20) show a p-value \< 0.025 when comparing pill counts (hypothesizing EX is superior to PB), proceed to Stage II. If not, continue enrollment to full sample size and reanalyze. If final p-value \< 0.025, EX is considered superior. If not significant, continue with EX. If EX is inferior to PB, conduct subset analysis and revise inclusion/exclusion criteria for Stage II. In Stage II, test BT efficacy using the superior AT. Enroll 60 patients, randomized 2:1 favoring CPT. Include Stage I patients treated with IOB and superior AT in analysis. Final sample sizes: n1 = 40 or 60, n2 = 40, maintaining ≥80% power.

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 27, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)