Neurometer vs Nerve Stimulator: Block Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01662154
First received: July 11, 2012
Last updated: May 21, 2015
Last verified: May 2015
  Purpose
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.

Condition Intervention
Nerve Block Assessment
Device: Neurometer assessment
Device: Nerve stimulator assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Percutaneous Nerve Stimulation as a Means to Assess Nerve Block Effectiveness

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Accuracy of nerve activity measurement. [ Time Frame: During nerve stimulation (approximately 30 seconds for each stimulation test) ] [ Designated as safety issue: No ]
    Testing whether a common nerve stimulator device detects nerve activity as accurately and consistently as the Neurometer.


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nerve stimulator
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
Activity of nerve(s) to be blocked will be assessed with the Stimuplex HNS 12 nerve stimulator before and after administration of local anesthetic.
Active Comparator: Neurometer
Patients in this group will have their nerve block assessed using the Neurometer.
Device: Neurometer assessment
Activity of nerve(s) to be blocked will be assessed with the Neurometer before and after administration of local anesthetic.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01662154

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
University of Alberta
  More Information

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

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01662154     History of Changes
Other Study ID Numbers: Pro00031858 
Study First Received: July 11, 2012
Last Updated: May 21, 2015
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on August 24, 2016