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

George Kokosis

Status: Begins enrollment this month

Conditions: Post-mastectomy Pain Syndrome

Treatments: Procedure: Regenerative Peripheral Nerve Interface

Study type: Interventional

Funder types: Other

Identifiers

NCT06580951

24042301

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

RPNI

Experimental group

Description:

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.

Treatment:

Procedure: Regenerative Peripheral Nerve Interface

No RPNI (Control)

No Intervention group

Description:

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.