Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface

Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)

Post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life. The investigators on this study will evaluate the regenerative peripheral nerve interface (RPNI), a novel surgical approach to neuroma treatment, to improve patient-reported post-mastectomy pain and definitively treat intercostal neuromas after mastectomy.

Up to 40% of patients who undergo mastectomy suffer from chronic pain, defined as pain lasting greater than three months. Chronic post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life. A novel surgical approach to neuroma treatment, the regenerative peripheral nerve interface (RPNI) developed to treat painful neuromas associated with limb amputation has shown significant reductions in patient-reported pain. RPNI surgery is now available through Michigan Medicine's Multi-Disciplinary Peripheral Nerve (MDPN) Clinic to improve post-mastectomy pain and definitively treat intercostal neuromas following mastectomy. Using patient-reported outcomes and clinical data the investigators will evaluate the use of RPNI surgery to reduce persistent post- mastectomy pain in women seeking surgical consultation through the Plastic Surgery or MDPN clinics.

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Reporting post-mastectomy pain at least six months removed from mastectomy or partial mastectomy (lumpectomy).
• Willing to comply with all study procedures and be available for the duration of the study
• Fluent in English
• Women of reproductive potential must use highly effective contraception (specify methods of contraception acceptable for the study, e.g., licensed hormonal methods) and/or willingness to undergo a pregnancy test.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Previous surgical management for chronic post-mastectomy pain
• Signs/symptoms which are not suggestive of neuropathic pain based on physical exam at time of consultation.
• Pregnancy or lactation
• Men will not be enrolled in this study due to the low prevalence of male mastectomy.
• Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.