N/A
Completed N=26
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface
Post-Mastectomy Chronic Pain Syndrome
Source: ClinicalTrials.gov NCT04530526 ↗
Enrolled (actual)
26
Serious AEs
—
Results posted
Dec 2025
Primary outcomePrimary: Change in Pain Level — 6.9; 0.6; 4.4; 2.5 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Level |
6.9; 0.6; 4.4; 2.5; 27.5; 14.1 | — |
| PRIMARY Change in Depression/Anxiety Scores |
10.3; 7.2; 7.3; 4.3 | — |
| PRIMARY Change in Opioid Consumption (Number of Opioid Medications) |
1.3; 0.4 | — |
| PRIMARY Freedom From Neuroma Recurrence Evaluated by Physical Exam |
20 | — |
| PRIMARY Freedom From Neuroma Recurrence Evaluated by Ultrasound |
20 | — |
| PRIMARY Change in Opioid Consumption (Oral Morphine Equivalents) |
43.3; 12.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04530526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.