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CompletedNCT02533024Updated Sep 25, 2017

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

An interventional study of Electromyography in Ulnar Neuropathy, sponsored by University of Toledo Health Science Campus. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by University of Toledo Health Science Campus · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ulnar Neuropathy
03

In context

Lead sponsor

University of Toledo Health Science Campus is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Group Cohort

    All subjects will have nerve conduction studies (Electromyography/EMG) pre-operatively, monitored intra-operatively and immediately post-operative.

    Other: Electromyography

Interventions

  • OtherElectromyography

    All subjects will have an EMG before, during and immediately after surgery.

    Also known as: EMG

06

What researchers measure

Primary outcomes

  1. Prevalence of ulnar neuropathy in patients scheduled to undergo anesthesia and surgery as measured by electromyography

    Prevalence of undiagnosed or subclinical ulnar neuropathy as determined by electromyography

    Time frame: Day 1

Secondary outcomes

  1. Amplitude (mV)

    Compare preoperative, perioperative and postoperative amplitude changes from EMG

    Time frame: Day 1

  2. Latency (ms)

    Compare preoperative, perioperative and postoperative latency changes from EMG

    Time frame: Day 1

  3. Velocity (m/s)

    Compare preoperative, perioperative and postoperative velocity changes from EMG

    Time frame: Day 1

07

Study locations

1 site
  • University of Toledo
    Toledo, Ohio 43614, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02533024
Lead sponsor
University of Toledo Health Science Campus
Responsible party
Sponsor
First posted
Aug 26, 2015
Start date
Aug 2015
Primary completion
Apr 28, 2017
Completion
Apr 28, 2017
Last update
Sep 25, 2017

Study contacts

Andrew B Casabianca, MD
principal investigator · University of Toledo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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