Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)
Purpose
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
- Breast Cancer
- Surgery
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single group
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IONM during ALND Breast Surgery |
Monitoring electrodes will be placed in the patient's scalp and along the cervical and brachial nerves and stimulating electrodes 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. |
|
Recruiting Locations
Cincinnati, Ohio 45219
UCCC Clinical Trials Office
More Details
- Status
- Recruiting
- Sponsor
- University of Cincinnati
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