Neurometer vs Nerve Stimulator: Block Patients

NCT01662154 | Terminated

• 1 other identifier: Pro00031858
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthetizing nerves in the extremities is an effective way to freeze an area in preparation for surgery. The doctor injects local anesthetic in an appropriate area, interrupting signals from nerves in that area that control movement and sensation. Depending on how much anesthetic is injected, the doctor can impair both movement and sensation or sensation alone. Currently, there are a few methods used to determine how much sensation a patient has in an area, such as testing the patient's response to a pinprick or cold sensation on the skin. Unfortunately, these methods are subjective and don't always give an accurate measurement of how extensive the block is. For this reason, a more accurate and objective method of assessing nerve blocks is needed. We wish to perform a study to test two nerve stimulation devices to compare their ability to give adequate measurements of nerve activity before and after local anesthesia. If we find that a common nerve stimulator can consistently give accurate readings of nerve activity, anesthesiologists may be able to use this device to determine how well a nerve block is working and adjust the patient's anesthesia accordingly.

Conditions

Nerve Block Assessment

Outcome Measures

Primary Outcomes (1)

• Accuracy of nerve activity measurement.

  Testing whether a common nerve stimulator device detects nerve activity as accurately and consistently as the Neurometer.

  During nerve stimulation (approximately 30 seconds for each stimulation test)

Study Arms (2)

Nerve stimulator

EXPERIMENTAL

Patients in this group will have their nerve blocks assessed with a common nerve stimulator (Stimuplex HNS 12, B.Braun, Germany).

Device: Nerve stimulator assessment

Neurometer

ACTIVE COMPARATOR

Patients in this group will have their nerve block assessed using the Neurometer.

Device: Neurometer assessment

Interventions

Neurometer assessment DEVICE

Activity of nerve(s) to be blocked will be assessed with the Neurometer before and after administration of local anesthetic.

Neurometer

Nerve stimulator assessment DEVICE

Activity of nerve(s) to be blocked will be assessed with the Stimuplex HNS 12 nerve stimulator before and after administration of local anesthetic.

Nerve stimulator

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years of age or older) patients who have provided informed consent.
• Outpatients scheduled for elective surgery on the upper or lower extremity or abdomen.
• Requirement for nerve block.

You may not qualify if:

• Failure to provide informed consent.
• Neuropathic lesions or polyneuropathic conditions.
• Implanted electrical devices (e.g., pacemaker, spinal cord or peripheral nerve stimulator).
• Allergy to local anesthetics.
• Severe coagulopathy.
• Bilateral upper limb surgery.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2C8, Canada

Location

Related Publications (5)

• Pither CE, Raj PP, Ford DJ. (1985) The use of peripheral nerve stimulators for regional anesthesia: A review of experimental characteristics, technique, and clinical implications. Reg. Anesth. 10:49-58.

  BACKGROUND

• Masson EA, Boulton AJ. The Neurometer: validation and comparison with conventional tests for diabetic neuropathy. Diabet Med. 1991;8 Spec No:S63-6. doi: 10.1111/j.1464-5491.1991.tb02159.x.

  PMID: 1825961 BACKGROUND

• NEUROMETER® Clinical and Research Update (2010 - 2011). Available at: http://www.neurotron.com/documents_downloads.html

  BACKGROUND

• Stimuplex® HNS 12 User Manual. B.Braun Melsungen AG. Available at: http://www.bbraun.com/cps/rde/xchg/bbraun-com/hs.xsl/products.html?prid=PRID00001835

  BACKGROUND

• "Generic IRB Application for Research Involving the Electrodiagnostic sensory Nerve Conduction Threshold (sNCT) Evaluation, August 19, 2004, Diagnostic Transcutaneous Electrical Stimulation in Individuals." Available at: http://www.neurotron.com/documents_downloads.html

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: August 10, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)