Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdvanced Reconstructive Surgery Alliance

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nerve Surgery
  • Standard of Care (Investigator Choice)

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations