Clinical trial · Interventional
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
NCT07528638CI-TRIAL-00116579recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IONM procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IONM during ALND Breast Surgery
- description
- 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.
- interventionNames
- Procedure: IONM procedure
Primary outcomes (1)
- measure
- Feasibility of being able to stimulate and record the ICBN and MBCN
- timeFrame
- Surgery
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.