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

NCT07528638 | Recruiting

• 1 other identifier: UCCC-BRE-25-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Breast Cancer; Surgery

Outcome Measures

Primary Outcomes (1)

• Feasibility of being able to stimulate and record the ICBN and MBCN

  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

  Surgery

Secondary Outcomes (3)

• 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

Study Arms (1)

IONM during ALND Breast Surgery

EXPERIMENTAL

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.

Procedure: IONM procedure

Interventions

IONM procedure 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.

IONM during ALND Breast Surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Medsurant Health/Evokes Neuromonitoring: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698; cancer@uchealth.com

Dale Horne

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 14, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

US (1)