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

September 21, 2017 updated by: University of Toledo Health Science Campus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • EMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude (mV)
Time Frame: Day 1
Compare preoperative, perioperative and postoperative amplitude changes from EMG
Day 1
Latency (ms)
Time Frame: Day 1
Compare preoperative, perioperative and postoperative latency changes from EMG
Day 1
Velocity (m/s)
Time Frame: Day 1
Compare preoperative, perioperative and postoperative velocity changes from EMG
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toledo Health Science Campus

Investigators

  • Principal Investigator: Andrew B Casabianca, MD, University of Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

April 28, 2017

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ulnar-Neuropathy-ULE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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