NCT06574022 Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
| NCT ID | NCT06574022 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Cincinnati |
| Condition | Mastectomy; Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-09-25 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06574022 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mastectomy; Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06574022 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06574022 currently recruiting?
Yes, NCT06574022 is actively recruiting participants. Contact the research team at cancer@uchealth.com for enrollment information.
Where is the NCT06574022 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06574022 clinical trial?
NCT06574022 is sponsored by University of Cincinnati. The trial plans to enroll 100 participants.