NCT07528638 · University of Cincinnati
Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)
What this study is about
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).
View original scientific description
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).
Interventions
PROCEDURE
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 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 outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cincinnati, Ohio
Collaborators
Medsurant Health/Evokes Neuromonitoring
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations