💬In plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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