Recruiting

Pain Management vs. Local Numbing

Sponsor:

University of Cincinnati

Code:

NCT06574022

Conditions

Mastectomy; Lymphedema

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacain

Exparel

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

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

Study Details

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

Study ID

NCT06574022

Start date

Sep 25, 2024

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents) [ Time Frame: 14 days post-operation ]
  • Postoperative pain as indicated by postoperative opioid use discontinuation [ Time Frame: 14 days post-operation ]

Central Contacts and Locations

Central contacts

UCCC Clinical Trials Office

513-584-7698cancer@uchealth.com

Locations

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

More Information

Sponsor

University of Cincinnati

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2025-11-04.