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.
Adult patients (≥18 years old) undergoing second-stage implant exchange as part of tissue expander based breast reconstruction.
Patients with no prior diagnosis of PMPS.
Prior nerve surgery in the chest region or chronic pain conditions unrelated to mastectomy.
Recent chest radiation (<6 months), severe scarring, or active infection.
Uncontrolled diabetes, high-dose corticosteroids, or immunosuppressive therapy.
Psychiatric or cognitive impairments.
Parallel
Nerve Surgery
Procedure/SurgeryPatients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.
Standard of Care (Investigator Choice)
Other interventionPatients 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.
Breast Cancer Pain Questionnaire
Pain severity scores at 3, 6, and 12 months.
Adverse event rates
Complication and adverse event rates.
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