Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)
Feasibility of Using Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND) to Provide Early Identification and Protection of the Intercostalbrachial Nerve (ICBN), Medial Branch Cutaneous Nerve (MBCN), and Their Branches
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests nerve monitoring and a different electric tool used during surgery to remove underarm lymph nodes. It checks whether these tools help surgeons find nerves linked to nerve pain after surgery sooner. It is for adults with breast cancer who are having this surgery.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 70 years old.
- A tissue test has confirmed that you have breast cancer.
- You will have underarm lymph nodes removed by a breast surgeon taking part in this study.
Who can't join
- You had earlier underarm surgery, other than a needle breast biopsy or sentinel lymph node biopsy (removal of the first lymph nodes checked for cancer spread).
- You developed nerve damage after breast radiation or chemotherapy, before this surgery.
- You have a nerve condition, nerve pain, or arm nerve injury; a disease that damages the covering around nerves; or damage in the brain’s parietal area.
- You had spine surgery, have a spine problem such as narrowed spaces or pinched nerves in the neck, or have trouble using an arm or leg.
- You take medicines or substances that affect nerve pain, such as gabapentin, certain antidepressants, numbing patches, opioids, cannabis, or Botox.
- You have major health problems, such as a clotting disorder treated with blood thinners, heart problems, or another condition that could affect long-term follow-up.
- Before surgery, you have breast, arm, or chest pain on the side where lymph nodes will be removed.
- Nerve monitoring failed during an earlier procedure you had.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
OH
- University of Cincinnati · Cincinnati, OH 45219UCCC Clinical Trials Office · Study contactDale Horne · Study contactMore trials in Cincinnati