Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regenerative Peripheral Nerve Interface.
- Who it may be relevant to
- Registry conditions: Post-mastectomy Pain Syndrome. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain
Overview
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.
Interventions
- Procedure Regenerative Peripheral Nerve Interface
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.
Primary outcome measures
- Incidence of neuroma-related PBSPS [Time frame: 12 months]
Secondary outcome measures (3)
- Quality of Life change [Time frame: 12 months]
- Safety and Adverse Events [Time frame: 12 months]
- Pain change [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Adult female 18 to 65 years of age.
- Undergoing breast mastectomy with immediate reconstruction.
- Able to provide informed consent and comply with study procedures.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06580951 · 24042301