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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Incidence of neuroma-related PBSPS [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Quality of Life change [Срок оценки: 12 months]
• Safety and Adverse Events [Срок оценки: 12 months]
• Pain change [Срок оценки: 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06580951 · 24042301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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