Comparing two nerve-block options to reduce pain after total mastectomy.
Post-mastectomy Recovery: A Randomized Clinical Trial Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
This test tries whether a PECS-II block given before surgery or a pectoral block given during surgery, using bupivacaine or liposomal bupivacaine, provides better pain control after total mastectomy for breast cancer or high-risk patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06574022 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for total mastectomy for breast cancer or high cancer risk at the University of Cincinnati Medical Center are the intended participants.
Not a fit: Patients undergoing only partial mastectomy or tissue-based reconstruction, those who are pregnant, non-English speaking, allergic to local anesthetics, or on recent opioid prescriptions are unlikely to qualify or benefit from this comparison.
Why it matters
Potential benefit: If successful, patients could have better immediate and longer-lasting pain relief after mastectomy and require fewer opioid pain medications.
How similar studies have performed: Previous trials have shown PECS and pectoral blocks and liposomal bupivacaine can reduce postoperative pain and opioid use, but direct head-to-head comparisons of preoperative versus intraoperative timing remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.