RecruitingNot ApplicableNCT07528638

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

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

Sponsor

University of Cincinnati

Enrollment

6 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Surgery

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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.

Exclusion Criteria12

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.

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Interventions

PROCEDUREIONM 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 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.