Clinical trial NCT06580951: Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
Official title: Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-mastectomy Pain Syndrome
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of neuroma-related PBSPS
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life change
timeFrame: 12 months
measure: Safety and Adverse Events
timeFrame: 12 months
measure: Pain change
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: George Kokosis, MD
role: PRINCIPAL_INVESTIGATOR
References: