Clinical trial · Interventional
Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial
- 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 Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain. Prophylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nerve Surgery | Procedure | — | UNRESOLVED |
| Standard of Care (Investigator Choice) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).
- interventionNames
- Other: Standard of Care (Investigator Choice)
- type
- EXPERIMENTAL
- label
- Nerve Surgery
- description
- Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.
- interventionNames
- Procedure: Nerve Surgery
Primary outcomes (1)
- measure
- Incidence of Post-Mastectomy Pain Syndrome
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (≥18 years old) undergoing second-stage implant exchange as part of tissue expander based breast reconstruction. * Patients with no prior diagnosis of PMPS. Exclusion Criteria: * Prior nerve surgery in the chest region or chronic pain conditions unrelated to mastectomy. * Recent chest radiation (\<6 months), severe scarring, or active infection. * Uncontrolled diabetes, high-dose corticosteroids, or immunosuppressive therapy. * Psychiatric or cognitive impairments. * Pregnancy, or active lactation. * Autologous tissue based breast reconstruction. * Participation in another study within 6 months or inability to comply with follow-up.
References
Publications (0)
Data not yet available