Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Cincinnati
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
IONM procedure
Procedure/SurgeryThis 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: IONM during ALND Breast SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of being able to stimulate and record the ICBN and MBCN
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
Time frame
SurgerySecondary outcomes
1
Identification of the stimulation and recording values from the ICBN and MBCN
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
Time frame
Surgery2
Identification of optimal stimulation current of the ICBN and MBCN main nerve trunks
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.
Time frame
Surgery3
Identification of optimal stimulation current of individual nerve branches of the ICBN and MBCN
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.
Time frame
SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cincinnati
Lead sponsor
Medsurant Health/Evokes Neuromonitoring
Collaborator
Source ClinicalTrials.gov