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NCT Number: NCT07528638

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location status: Recruiting

Location contact

Dale Horne

CONTACT

UCCC Clinical Trials Office

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of being able to stimulate and record the ICBN and MBCN

    Time frame: 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

Secondary outcomes

  1. Identification of the stimulation and recording values from the ICBN and MBCN

    Time frame: Surgery

    In this study 6 subjects will undergo ALND by the surgical breast oncologist. In each of these cases the surgeon will attempt to dissect and expose the ICBN and MBCN using visual anatomical guidelines. In most cases, the main trunks of these nerves can be identified visually and anatomically. Once the nerves are exposed, they will be stimulated directly and individually. The starting points for the stimulation and recording parameters will come from the responses for the median and ulnar nerves in each corresponding patient. These

  2. Identification of optimal stimulation current of the ICBN and MBCN main nerve trunks

    Time frame: Surgery

    In this study 6 subjects will undergo ALND by the surgical breast oncologist. In each of these cases the surgeon will attempt to dissect and expose the ICBN and MBCN using visual anatomical guidelines. Establishing that the ICBN and MBCN trunks stimulate and provide SSEP responses is an essential focus, and the specific stimulation and recording parameters will be noted. The most optimal stimulation current is the lowest current that reliably and reproducibly provides adequate SSEPs. This optimal stimulation current will be determined for the ICBN and MBCN main nerve trunks.

  3. Identification of optimal stimulation current of individual nerve branches of the ICBN and MBCN

    Time frame: Surgery

    In this study 6 subjects will undergo ALND by the surgical breast oncologist. In each of these cases the surgeon will attempt to dissect and expose the ICBN and MBCN using visual anatomical guidelines. The optimal stimulation and recording parameters will be a starting point to sample the tissues nearby each of these main nerve trunks to determine whether any associated and/or smaller branches of the ICBN and MBCN nerves exist. The stimulating and recording parameters will be noted as well. The quadrant (SM, SL, IM, IL-as outlined in the protocol) of any tissue that stimulates and gives a SSEP response will be noted along with the stimulating and recording parameters.

Study contacts

Contact information is provided by the study sponsor or research team.

Dale Horne

CONTACT

UCCC Clinical Trials Office

CONTACT

[email protected]

513-584-7698

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Medsurant Health/Evokes Neuromonitoring

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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