Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Cincinnati
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 with any pre-existing neurological conditions affecting nerves, such as neuropathy (peripheral neuropathy, neuropathic pain or nerve injury to upper extremity).
Trial design
Treatments tested in this trial
- IONM procedure
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Cincinnati
Lead sponsor
Medsurant Health/Evokes Neuromonitoring
Collaborator
Source ClinicalTrials.gov