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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02533024
Other study ID # Ulnar-Neuropathy-ULE
Secondary ID
Status Completed
Phase N/A
First received August 20, 2015
Last updated September 21, 2017
Start date August 2015
Est. completion date April 28, 2017

Study information

Verified date September 2016
Source University of Toledo Health Science Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date April 28, 2017
Est. primary completion date April 28, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Toledo Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
Secondary Amplitude (mV) Compare preoperative, perioperative and postoperative amplitude changes from EMG Day 1
Secondary Latency (ms) Compare preoperative, perioperative and postoperative latency changes from EMG Day 1
Secondary Velocity (m/s) Compare preoperative, perioperative and postoperative velocity changes from EMG Day 1
See also
  Status Clinical Trial Phase
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A