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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface

NCT04530526

Post-Mastectomy Chronic Pain Syndrome

COMPLETED NA

A Study on Pain After Breast Reconstruction

NCT06627582

Mastectomy Mastectomy Patient Mastectomy and Breast Reconstruction +3 more

RECRUITING NA

Cryoablation for Post Mastectomy Pain Syndrome

NCT03293940

Post-Mastectomy Chronic Pain Syndrome (Disorder)

COMPLETED NA

Comparative Evaluation of Pectoral Nerve Block Type II Versus Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Mastectomy for Postoperative Analgesia: a Randomized, Controlled Trial

NCT06760429

Breast Cancer

COMPLETED EARLY_PHASE1

Autologous Nerve Graft Breast Reconstruction Neurotization

NCT06629012

Breast Reconstruction Breast Cancer Patients Nipple-sparing Mastectomy

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of care

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

Group Type ACTIVE_COMPARATOR

Standard of Care (Investigator Choice)

Intervention Type OTHER

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

Nerve Surgery

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

Group Type EXPERIMENTAL

Nerve Surgery

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nerve Surgery

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

Intervention Type PROCEDURE

Standard of Care (Investigator Choice)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No