Breast Cancer, Surgery
Conditions
Brief 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
Interventions
PROCEDUREIONM 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
University of Cincinnati
Medsurant Health/Evokes Neuromonitoring
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single group
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients ages 18-70 years old. 2. Pathologically confirmed diagnosis of breast cancer. 3. Undergoing ALND by one of the breast surgeon Sub-Investigators on this study.
Exclusion criteria
1. Patients having any previous axillary surgery other than percutaneous breast biopsy and/or SLNB. 2. Prior breast radiation with neuropathy clearly developing after radiation. 3. Patients who have undergone prior chemotherapy and developed post-chemotherapy neuropathy prior to ALND. 4. Patients with any pre-existing neurological conditions affecting nerves, such as neuropathy (peripheral neuropathy, neuropathic pain or nerve injury to upper extremity). 5. 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). 6. Patients with prior spinal surgery or spinal pathology (cervical spinal stenosis or cervical radiculopathy). 7. Patients with limb-dysfunction. 8. Patients with demyelinating disease. 9. Patients with significant co-morbidities (clotting disorders on anticoagulation, cardiac issues, other conditions that could impact long-term follow-up). 10. Patients that present with pre-operative breast, arm or chest pain ipsilateral to anticipated ALND. 11. Patients who have had prior procedures where IONM failed intraoperatively. 12. Presence of parietal cortical lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of being able to stimulate and record the ICBN and MBCN | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of the stimulation and recording values from the ICBN and MBCN | Surgery | 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 |
| Identification of optimal stimulation current of the ICBN and MBCN main nerve trunks | Surgery | 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. |
| Identification of optimal stimulation current of individual nerve branches of the ICBN and MBCN | Surgery | 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. |
Countries
United States
Contacts
CONTACTUCCC Clinical Trials Office
CONTACTDale Horne
Outcome results
None listed