NCT07146009

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Advanced Reconstructive Surgery Alliance · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Nerve Surgery	Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.
OTHER	Standard of Care (Investigator Choice)	Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2028-02-25
• First posted: 2025-08-28
• Last updated: 2025-08-28