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Preoperative Prevalence of Ulnar Neuropathy and Changes in Ulnar Nerve Latency During Surgery

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ClinicalTrials.gov Identifier: NCT02533024
Recruitment Status : Completed
First Posted : August 26, 2015
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Toledo Health Science Campus

Brief Summary:
This study is to investigate the incidence of undiagnosed ulnar neuropathy in patients undergoing surgery. The investigators hope to determine if patients with ulnar neuropathy have changes in nerve conduction latency during surgery.

Condition or disease Intervention/treatment Phase
Ulnar Neuropathy Other: Electromyography Not Applicable

Detailed Description:
After obtaining an informed consent, the participating subjects will be asked a few questions relating to ulnar nerve dysfunction. Following this the investigators will do a focused physical exam looking for decrement of sensation in the distribution of the ulnar nerve and muscle strength of the hand muscles supplied by the ulnar nerve. After this the subjects will undergo an EMG exam to measure the conduction velocity of the ulnar nerve. Basically the nerve will be stimulated with a small current and the resultant muscle activity of the hand muscle will be picked up using an EKG like patch applied to the skin over the hand. If a subject is diagnosed to have ulnar neuropathy preoperatively the investigators would study the EMG based nerve conduction during surgery at 30-60 minute intervals for the duration of surgery. For purposes of comparison the investigators would measure the ulnar nerve conduction during surgery in age and sex matched controls.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preoperative Prevalence of Ulnar Neuropathy and Changes in Ulnar Nerve Latency During Surgery
Study Start Date : August 2015
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Arm Intervention/treatment
Experimental: Group Cohort
All subjects will have nerve conduction studies (Electromyography/EMG) pre-operatively, monitored intra-operatively and immediately post-operative.
Other: Electromyography
All subjects will have an EMG before, during and immediately after surgery.
Other Name: EMG




Primary Outcome Measures :
  1. Prevalence of ulnar neuropathy in patients scheduled to undergo anesthesia and surgery as measured by electromyography [ Time Frame: Day 1 ]
    Prevalence of undiagnosed or subclinical ulnar neuropathy as determined by electromyography


Secondary Outcome Measures :
  1. Amplitude (mV) [ Time Frame: Day 1 ]
    Compare preoperative, perioperative and postoperative amplitude changes from EMG

  2. Latency (ms) [ Time Frame: Day 1 ]
    Compare preoperative, perioperative and postoperative latency changes from EMG

  3. Velocity (m/s) [ Time Frame: Day 1 ]
    Compare preoperative, perioperative and postoperative velocity changes from EMG



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50 yrs of age or older
  • Scheduled to undergo a surgical procedure at UTMC with an anticipated length of 2hours or greater

Exclusion Criteria:

  • Less than 50yrs
  • Not scheduled for a surgical procedure at UTMC or scheduled for a surgical procedure with an anticipated length of less than 2hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533024


Locations
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United States, Ohio
University of Toledo
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
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Principal Investigator: Andrew B Casabianca, MD University of Toledo

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Responsible Party: University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT02533024     History of Changes
Other Study ID Numbers: Ulnar-Neuropathy-ULE
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2016
Additional relevant MeSH terms:
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Ulnar Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Mononeuropathies