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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nerve Surgery

Procedure

Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.

Standard of Care (Investigator Choice)

Other

Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).

Primary outcomes

Incidence of Post-Mastectomy Pain Syndrome

Time frame: Pre-operative visit (baseline) to 12 months.

Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively.

Secondary outcomes

Breast Cancer Pain Questionnaire

Time frame: Pre-operative visit (baseline) to 12 months.

Pain severity scores at 3, 6, and 12 months.
Adverse event rates

Time frame: Pre-operative visit (baseline) to 12 months.

Complication and adverse event rates.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Wells, BS

CONTACT

[email protected]

732-741-0970 ext. 1889

Sponsors and collaborators

Lead sponsor

Advanced Reconstructive Surgery Alliance

Other Gov

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Aug 28, 2025
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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