NCT07528638Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 29 Jun 2026
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- University of Cincinnati
- NCT number
- NCT07528638
What you commit to
- Study type: Interventional
- Planned participants: 6
- From 29 Jun 2026 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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).
- Patients with prior spinal surgery or spinal pathology (cervical spinal stenosis or cervical radiculopathy).
- Patients who have had prior procedures where IONM failed intraoperatively.
Other illness
- Patients with any pre-existing neurological conditions affecting nerves, such as neuropathy (peripheral neuropathy, neuropathic pain or nerve injury to upper extremity).
- Patients with demyelinating disease.
- Patients with significant co-morbidities (clotting disorders on anticoagulation, cardiac issues, other conditions that could impact long-term follow-up).
Other
- Patients with limb-dysfunction.
- Patients that present with pre-operative breast, arm or chest pain ipsilateral to anticipated ALND.
- Presence of parietal cortical lesion.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.