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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Post-Mastectomy Chronic Pain Syndrome

Treatments: Procedure: Regenerative Peripheral Nerve Interface

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04530526

HUM00149189 (Other Identifier)

UMCC 2018.124

R21CA234760 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Regenerative Peripheral Nerve Interface (RPNI)

Other group

Description:

Using evaluative ultrasound measurements and a standard panel of patient-reported outcome measures (PROMs) to measure pain experience, anxiety and depression, patients will be evaluated at baseline (T1=0months), pre-operatively following 3 months of standard neuropathic pain management therapy (T2=3months) and at three months (T3=6months) and nine months (T4=12months) post RPNI surgery.

Treatment:

Procedure: Regenerative Peripheral Nerve Interface