Breast Cancer
Conditions
Keywords
Post-mastectomy pain syndrome (PMPS), Breast reconstruction, Regenerative Peripheral Nerve Interfaces, Targeted Muscle Reinnervation
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 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
PROCEDURENerve Surgery
Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.
Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).
Sponsors
Advanced Reconstructive Surgery Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-Mastectomy Pain Syndrome | Pre-operative visit (baseline) to 12 months. | Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cancer Pain Questionnaire | Pre-operative visit (baseline) to 12 months. | Pain severity scores at 3, 6, and 12 months. |
| Adverse event rates | Pre-operative visit (baseline) to 12 months. | Complication and adverse event rates. |
Contacts
Primary ContactGrace Wells, BS
Outcome results
None listed