NCT07528638

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed 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). 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

Conditions

• Breast Cancer
• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States