IONM and Bipolar Electrocautery During Breast Cancer Surgery
This study is looking at new ways to identify nerves during breast cancer surgery called Axillary Lymph Node Dissection (ALND). Researchers are testing if using Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) can help surgeons find and protect nerves like the Intercostobrachial Nerve (ICBN) and Medial Brachial Cutaneous Nerve (MBCN). These nerves, if injured, can cause long-lasting pain after surgery. The study aims to see if these techniques can reliably locate these nerves. You may be able to join if you are 18-70 years old, have breast cancer, and are having ALND surgery. The study is currently unclear on its recruitment status and plans to enroll 6 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention. It is designed to enroll 6 participants.
- What's involved
- Electrodes will be placed by an IONM technician after you are asleep for surgery. The primary endpoint is measured at the time of surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at surgery, so follow-up beyond that time is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Feasibility of being able to stimulate and record the ICBN and MBCNSurgery
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