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NCT Number: NCT04530526

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

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.

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Key information

Conditions

Post-Mastectomy Chronic Pain Syndrome Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Neuroma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Pain Level

    Time frame: baseline, and 9 months post surgery

    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

  2. Change in Depression/Anxiety Scores

    Time frame: baseline, and 9 months post surgery

    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.

  3. Change in Opioid Consumption (Number of Opioid Medications)

    Time frame: baseline, and 9 months post surgery

    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.

  4. Freedom From Neuroma Recurrence Evaluated by Physical Exam

    Time frame: 24 months post enrollment

    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.

  5. Freedom From Neuroma Recurrence Evaluated by Ultrasound

    Time frame: 24 months post enrollment

    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.

  6. Change in Opioid Consumption (Oral Morphine Equivalents)

    Time frame: baseline, and 9 months post surgery

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: RPNI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2020
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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