Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome

NCT06580951 | Not Yet Recruiting

• 1 other identifier: 24042301
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. In the decade that followed, it was found RPNI surgery not only provided amputees with neuroma (a growth made up nerve tissue) pain relief but could help prevent neuroma from developing as well. This single center, randomized controlled, investigator-initiated study will look at whether the RPNI, a nerve burying procedure involving protecting sensory nerves with a small piece of the patient's pectoralis muscle, performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent and/or reduce the risk for long-term nerve pain after breast cancer surgery (also called neuroma-related post-breast surgery pain syndrome (PBSPS)) versus the standard surgery alone (Control group). Symptoms of PBSPS include discomfort, numbness, tingling, and shooting pain in the chest and breast area. It is relatively common and may have many causes. About 200 adult females (18-65 years old) who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study. Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Study participants will complete self-reported surveys (pre-surgery and at Months 1, 3, 6, and 12 post-surgery) designed to measure pain levels, quality of life, and function before and after surgery. Study participation will last approximately 12 months. Subjects will remain blinded to their assigned study arm until their study participation has concluded.

Conditions

Post-mastectomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of neuroma-related PBSPS

  The study's primary endpoint will be the incidence of neuroma-related PBSPS, assessed by comparing the proportion of participants in each group who experience this condition during a follow-up period of 12 months, through review of electronic medical records.

  12 months

Secondary Outcomes (3)

• Quality of Life change

  12 months

• Safety and Adverse Events

  12 months

• Pain change

  12 months

Study Arms (2)

RPNI

EXPERIMENTAL

Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects will in the RPNI arm will undergo mastectomy with breast reconstruction surgery with regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records.

Procedure: Regenerative Peripheral Nerve Interface

No RPNI (Control)

NO INTERVENTION

Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects undergo mastectomy with breast reconstruction surgery without regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records.

Interventions

Regenerative Peripheral Nerve Interface PROCEDURE

The RPNI portion of the case will consist of blunt dissection of the cut sensory branches of the intercostal nerves at the T3 and/or T4 levels, with creation of a peripheral nerve interface using a small cuff of dissected pectoralis muscle and 3-0 Monocryl suture. The breast reconstruction will otherwise be performed as per standard protocol.

RPNI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Recruitment is limited to females as virtually all cases of breast cancer, and associated mastectomy and reconstruction procedures, are in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female 18 to 65 years of age.
• Undergoing breast mastectomy with immediate reconstruction.
• Able to provide informed consent and comply with study procedures.

You may not qualify if:

• History of chronic pain syndrome unrelated to breast surgery.
• Unwillingness or inability to comply with the study's follow-up requirements.
• Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments.
• Participation in other interventional trials or treatments aimed at pain management that could confound study outcomes as determined by the PI.
• Other medical or surgical contraindication to the involved procedure (RPNI) as determined by the PI.

Sponsors & Collaborators

• George Kokosis: lead

Study Officials

• George Kokosis, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Administrator

CONTACT

312-942-5500; anna_t_alecci@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Subjects will remain blinded to their assigned study arm until their study participation has concluded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 30, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share