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

NCT04530526 | Completed Results

• 3 other identifiers: UMCC 2018.124HUM00149189R21CA234760
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Mastectomy Chronic Pain Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Change in Pain Level

  The use of RPNI surgery to reduce post-mastectomy pain will be evaluated by validated patient-reported outcome (PRO) surveys administered at 4 timepoints: at baseline (at time of enrollment), at the RPNI pre-operative visit (approximately 3 months after enrollment), and at approximately 3 and 9 months after RPNI surgery. The average time of study involvement for each patient will be 12 months. Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops. Numerical Pain Rating Scale (0-10)- 10 indicating more pain Short Form McGill Pain Questionnaire 2 (0-10)- 10 indicating more pain Pain Catastrophizing Score (0-52)- 52 indicating more pain PROMIS Intensity (0-12)- 12 indicating more pain PROMIS Interference (0-24)- 24 indicating more pain PROMIS Neuropathic (0-20)- 20 indicating more pain

  baseline, and 9 months post surgery

• Change in Depression/Anxiety Scores

  Evaluated by validated patient-reported outcome (PRO) surveys administered at 4 timepoints: at baseline (at time of enrollment), at the RPNI pre-operative visit (approximately 3 months after enrollment), and at approximately 3 and 9 months after RPNI surgery. The average time of study involvement for each patient will be 12 months. Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops. Patient Health Questionnaire-9 range is 0-27. 27 indicates a worse outcome. Generalized Anxiety Disorder-7 range is 0-21. 21 indicates a worse outcome.

  baseline, and 9 months post surgery

• Change in Opioid Consumption (Number of Opioid Medications)

  Evaluated by validated patient-reported outcome (PRO) surveys administered at 4 timepoints: at baseline (at time of enrollment), at the RPNI pre-operative visit (approximately 3 months after enrollment), and at approximately 3 and 9 months after RPNI surgery. The average time of study involvement for each patient will be 12 months. Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.

  baseline, and 9 months post surgery

• Freedom From Neuroma Recurrence Evaluated by Physical Exam

  Data will be derived from standard clinical care for patients seeking surgical management of post-mastectomy chronic pain. Physical examinations will be performed at the time of patient enrollment and subsequent follow-up visits, as part of routine clinical evaluation, up to approximately 9 months after RPNI surgery. Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.

  24 months post enrollment

• Freedom From Neuroma Recurrence Evaluated by Ultrasound

  Data will be derived from standard clinical care for patients seeking surgical management of post-mastectomy chronic pain. Ultrasound will be performed at the time of patient enrollment and subsequent follow-up visits, as part of routine clinical evaluation, up to approximately 9 months after RPNI surgery. Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.

  24 months post enrollment

• Change in Opioid Consumption (Oral Morphine Equivalents)

  Evaluated by validated patient-reported outcome (PRO) surveys administered at 4 timepoints: at baseline (at time of enrollment), at the RPNI pre-operative visit (approximately 3 months after enrollment), and at approximately 3 and 9 months after RPNI surgery. The average time of study involvement for each patient will be 12 months. Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.

  baseline, and 9 months post surgery

Study Arms (1)

Regenerative Peripheral Nerve Interface (RPNI)

OTHER

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.

Procedure: Regenerative Peripheral Nerve Interface

Interventions

Regenerative Peripheral Nerve Interface 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.

Regenerative Peripheral Nerve Interface (RPNI)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 41133892 DERIVED

MeSH Terms

Conditions

Neuroma

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• David L Brown, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: July 12, 2019
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)