Comparing two nerve-block options to reduce pain after total mastectomy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional trial at the University of Cincinnati compares preoperative PECS-II nerve blocks with intraoperative pectoral blocks for people undergoing total mastectomy. Participants receive standard-of-care local anesthetics (bupivacaine or liposomal bupivacaine) with the assigned block technique. The main outcomes are postoperative pain control and opioid use during recovery. The protocol includes adults having total mastectomy with or without axillary surgery or reconstruction at the study site.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Cincinnati Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: UCCC Clinical Trials Office
• Email: cancer@uchealth.com
• Phone: 513-584-7698

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.