Clinical trial · Interventional
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)
NCT04530526CI-TRIAL-00099589RPNIcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post-Mastectomy Chronic Pain Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regenerative Peripheral Nerve Interface | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Regenerative Peripheral Nerve Interface (RPNI)
- 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.
- interventionNames
- Procedure: Regenerative Peripheral Nerve Interface
Primary outcomes (6)
- measure
- Change in Pain Level
- timeFrame
- baseline, and 9 months post surgery
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNag 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