Comparing Pain Management for Mastectomy Recovery

This study is comparing two ways to manage pain after a mastectomy (surgery to remove a breast). Researchers are looking at two different methods of giving local numbing medicine: a PECS-II block given before surgery, or a Pectoral block given during surgery. The numbing medicines being used are Bupivacaine and Exparel (liposomal bupivacaine), both standard treatments. You may be able to join if you are 18 or older and having a mastectomy for breast cancer or a high risk of breast cancer, including those with BRCA1 or BRCA2 genetic mutations. The main goal is to see how much opioid pain medication you use and when you stop using it in the 14 days after surgery.

Study design
This interventional study plans to enroll 100 participants. It compares different ways of giving pain medication.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain medication use will be measured for 14 days after your operation.

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NCT06574022

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

Recruiting
PHASE4Ages 18+InterventionalSupportive care
University of Cincinnati
~100 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:BupivacainExparelIntraoperative Pecs II block (IOB) & superior AT (EX or BP)Preoperative Pecs II block (POB) & superior AT (EX or BP)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)
Measured over 14 days post-operation
+1 more outcome measured
Mastectomy; Lymphedema
Breast Cancer
1 sites across 1 states
Ohio1

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Eligibility criteria

Inclusion

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

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).
  • Postoperative pain as indicated by postoperative opioid use via total inpatient and outpatient opioid use (oral morphine milliequivalents)14 days post-operation

    Post-operative opioid usage as measured by total inpatient and outpatient opioid use (oral morphine milliequivalents) through 14 days post-op.

  • Postoperative pain as indicated by postoperative opioid use discontinuation14 days post-operation

    Post-operative opioid usage as measured by time to opiate discontinuation through 14 days post-op.