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

Advanced Reconstructive Surgery Alliance

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Procedure: Nerve Surgery; Other: Standard of Care (Investigator Choice)

Study type: Interventional

Funder types: Other

Identifiers

NCT07146009

R-2025.02.25.01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Pregnancy, or active lactation.
• Autologous tissue based breast reconstruction.
• Participation in another study within 6 months or inability to comply with follow-up.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).

Treatment:

Other: Standard of Care (Investigator Choice)

Nerve Surgery

Experimental group

Description:

Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.

Treatment:

Procedure: Nerve Surgery