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

NCT ID: NCT04530526

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-12
• Study Completion Date: 2023-09-30

Brief Summary

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.

Detailed 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.

Conditions

Post-Mastectomy Chronic Pain Syndrome

Keywords

neuroma,outcome-assessment health care, post-mastectomy; outcome-assessment health care; post-mastectomy; neuroma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regenerative Peripheral Nerve Interface (RPNI)

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.

Group Type: OTHER

Regenerative Peripheral Nerve Interface

Intervention Type: PROCEDURE

The regenerative peripheral nerve interface (RPNI) has emerged as a novel strategy to treat neuromas in peripheral nerves. The RPNI consists of the residual peripheral nerve end implanted in a skeletal muscle graft, following surgical resection of the injured terminal nerve portion (neuroma). The free muscle graft is separated from its native nerve innervation, leaving open neuromuscular junctions for ingrowth and attachment of nerve fibers from the implanted nerve.

Interventions

Regenerative Peripheral Nerve Interface

The regenerative peripheral nerve interface (RPNI) has emerged as a novel strategy to treat neuromas in peripheral nerves. The RPNI consists of the residual peripheral nerve end implanted in a skeletal muscle graft, following surgical resection of the injured terminal nerve portion (neuroma). The free muscle graft is separated from its native nerve innervation, leaving open neuromuscular junctions for ingrowth and attachment of nerve fibers from the implanted nerve.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David L Brown, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

References

Nag S, Kennedy P, Aris K, Moore AM, Farhadi R. The Role of Nerve Surgery in the Management of Post-Breast Surgery Pain Syndrome: A Systematic Review and Meta-analysis. Ann Plast Surg. 2025 Dec 1;95(6):625-629. doi: 10.1097/SAP.0000000000004516. Epub 2025 Oct 16.

Reference Type: DERIVED

PMID: 41133892 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00149189

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA234760

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2018.124

Identifier Type: -

Identifier Source: org_study_id