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

NCT07528638 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medsurant Health/Evokes Neuromonitoring

    collaborator UNKNOWN

  • University of Cincinnati

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-01
Completion
2027-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528638 on ClinicalTrials.gov