Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nerve Surgery, Standard of Care (Investigator Choice).
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Nerve Surgery
Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction. - Other Standard of Care (Investigator Choice)
Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).
Primary outcome measures
- Incidence of Post-Mastectomy Pain Syndrome [Time frame: Pre-operative visit (baseline) to 12 months.]
Secondary outcome measures (2)
- Breast Cancer Pain Questionnaire [Time frame: Pre-operative visit (baseline) to 12 months.]
- Adverse event rates [Time frame: Pre-operative visit (baseline) to 12 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07146009 · R-2025.02.25.01