No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
6 (estimated)
Sponsor
University of Cincinnati · Other
Who this trial is looking for
This trial is looking for women aged 18-70 who have been diagnosed with breast cancer. Participants will have a specific type of surgery called axillary lymph node dissection and will be monitored for nerve activity during the operation.
Are You a Good Fit for This Trial?
Must not be takingGabapentinPregabalinDuloxetineVenlafaxineLidocaine patchesCapsaicin
Rules you outDemyelinating disease
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with breast cancer.
I will have axillary lymph node dissection by a surgeon participating in the trial.
You may not be able to join if
I have had any previous axillary surgery except for a biopsy.
I had breast radiation and developed nerve pain after that.
I had chemotherapy and developed nerve pain before the surgery.
I have any pre-existing nerve conditions.
I am taking medications that change nerve pain.
I have had spinal surgery or spinal problems.
I have any issues with limb function.
I have a demyelinating disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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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…
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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