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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Feasibility of being able to stimulate and record the ICBN and MBCN
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
IONM during ALND Breast Surgery
Monitoring electrodes will be placed in the patient's scalp and along the cervical and brachial nerves and stimulating electrodes will be placed to stimulate the median and ulnar nerves. Although IONM techniques have been used in other specialties to monitor a variety of different nerves to make surgery safer, monitoring of the ICBN and MBCN has never been performed. This pilot study is to determine the stimulating and recording parameters for these nerves by using the known parameters for the median and ulnar nerves as a starting point. Continuously monitoring the function of the median and ulnar nerves will also provide an integrity check of the recording system during surgical cases.
干预措施: IONM procedure (Procedure)
结局指标
主要结局
Feasibility of being able to stimulate and record the ICBN and MBCN
时间窗: Surgery
The median and ulnar nerves will be stimulated at the beginning and throughout surgeryt. SSEPs will be recorded to ensure that the subject's nerves are appropriately responding to stimulation and that responses are similar to knwon parameters. The stimulating current and SSEP responses for N9 (brachial plexus), Cervical spine, and N20 (cortical) must be present and within acceptable levels (15%) of expected responses. A list of all stimulation parameters and corresponding SSEPs for the median and ulnar nerves will be recorded. At the end of the surgical case closing potentials will be obtained and compared to initial baselines to ensure the stability of neuromonitoring. Feasibility of being able to stimulate and record the ICBN and MBCN will be determined by: (A) SSEP Amplitude, Latency, and correlation of appropriate site and side of SSEP recording relative to stimulation (B) Reproducibility and consistency of responses to stimulation
次要结局
- Identification of the stimulation and recording values from the ICBN and MBCN(Surgery)
- Identification of optimal stimulation current of the ICBN and MBCN main nerve trunks(Surgery)
- Identification of optimal stimulation current of individual nerve branches of the ICBN and MBCN(Surgery)
研究者
Dale Horne
Principal Investigator
University of Cincinnati