Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)

Официальное название

Feasibility of Using Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND) to Provide Early Identification and Protection of the Intercostalbrachial Nerve (ICBN), Medial Branch Cutaneous Nerve (MBCN), and Their Branches

Обзор

The purpose of this study is to determine whether the implementation of existing neurosurgical techniques of intraoperative neuromonitoring (IONM) and the replacement of monopolar electrocautery with bipolar electrocautery (BE), during ALND, will improve the early identification of nerves that have been implicated in the cause of neuropathically-mediated post-surgical pain syndrome (PSPS).

Подробное описание

The purpose of this study is to determine whether the implementation of existing neurosurgical techniques of intraoperative neuromonitoring (IONM) and the replacement of monopolar electrocautery with bipolar electrocautery (BE), during ALND, will improve the early identification of nerves that have been implicated in the cause of neuropathically-mediated post-surgical pain syndrome (PSPS). The cutaneous nerves most often injured and/or volitionally sacrificed are the ICBN and MBCN nerves which, when injured, result in neuropathic pain that can be significant and a source of chronic ipsilateral arm, chest wall, and breast pain. Some preliminary data exists regarding preservation of these nerves and suggests lower rates of PSPS when the nerves are able to be visually identified and kept intact. Being able to identify the nerves through electrical stimulation may help locate the nerves and their branches when they are not able to be visually identified. Furthermore, using BE instead of monopolar electrocautery produces less current and heat spread which may protect the nerves that are not initially visible.

This study is a first step in assessing the feasibility of using IONM and specifically, somatosensory evoked potentials (SSEP) and direct electrical stimulation (DES), to reliably and efficiently identify the ICBN, MBCN, and their branches.

The primary objective of this project is to establish the stimulating and recording parameters for reproducibly and efficiently identifying the ICBN, MBCN, and their branches during ALND

Вмешательства

• Процедура IONM procedure
  This study is designed to determine the feasibility of using IONM to identify and confirm the location of the ICBN and MBCN, and their branches, during ALND breast surgery. Once the patient is asleep after the induction of anesthesia, electrodes will be placed by the IONM technician. Monitoring electrodes will be placed in the patient's scalp and along the cervical and brachial nerves and stimulating elecctrodes will be placed to stimulate the median and ulnar nerves. Although IONM techniques ha

Первичные конечные точки

• Feasibility of being able to stimulate and record the ICBN and MBCN [Срок оценки: Surgery]

Вторичные конечные точки (3)

• Identification of the stimulation and recording values from the ICBN and MBCN [Срок оценки: Surgery]
• Identification of optimal stimulation current of the ICBN and MBCN main nerve trunks [Срок оценки: Surgery]
• Identification of optimal stimulation current of individual nerve branches of the ICBN and MBCN [Срок оценки: Surgery]

Критерии участия

Критерии включения

• Patients ages 18-70 years old.
• Pathologically confirmed diagnosis of breast cancer.
• Undergoing ALND by one of the breast surgeon Sub-Investigators on this study.

Критерии исключения

• Patients having any previous axillary surgery other than percutaneous breast biopsy and/or SLNB.
• Prior breast radiation with neuropathy clearly developing after radiation.
• Patients who have undergone prior chemotherapy and developed post-chemotherapy neuropathy prior to ALND.
• Patients with any pre-existing neurological conditions affecting nerves, such as neuropathy (peripheral neuropathy, neuropathic pain or nerve injury to upper extremity).
• Patients taking medications that are known to modify neuropathic pain (eg, gabapentin, pregabalin, duloxetine, venlafaxine, lidocaine patches, capsaicin, opioids, tramadol, NMDA receptor antagonists, clonidine, cannabis, botox).
• Patients with prior spinal surgery or spinal pathology (cervical spinal stenosis or cervical radiculopathy).
• Patients with limb-dysfunction.
• Patients with demyelinating disease.
• Patients with significant co-morbidities (clotting disorders on anticoagulation, cardiac issues, other conditions that could impact long-term follow-up).
• Patients that present with pre-operative breast, arm or chest pain ipsilateral to anticipated ALND.
• Patients who have had prior procedures where IONM failed intraoperatively.
• Presence of parietal cortical lesion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Cincinnati — Cincinnati

Идентификаторы

NCT: NCT07528638 · UCCC-BRE-25-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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