Status:
NOT_YET_RECRUITING
Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial
Lead Sponsor:
Advanced Reconstructive Surgery Alliance
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07146009
Start Date
October 1 2025
End Date
February 25 2028
Last Update
August 28 2025
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