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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.
Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).
Incidence of Post-Mastectomy Pain Syndrome
Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively.
Time frame: Pre-operative visit (baseline) to 12 months.
Breast Cancer Pain Questionnaire
Pain severity scores at 3, 6, and 12 months.
Time frame: Pre-operative visit (baseline) to 12 months.
Adverse event rates
Complication and adverse event rates.
Time frame: Pre-operative visit (baseline) to 12 months.
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