Clinical Trial

Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial

Not Yet Recruiting
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Summary
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain. Prophylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.
Trial Details
NCT Number NCT07146009
Lead Sponsor Advanced Reconstructive Surgery Alliance
Conditions Breast Cancer
Enrollment 60 participants
Start Date 2025-10
Primary Completion 2027-10 (estimated)
Study Completion 2028-02-25 (estimated)
Updated on ClinicalTrials.gov 2025-08-28