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

Primary Purpose

Ulnar Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electromyography
Sponsored by
University of Toledo Health Science Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulnar Neuropathy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Toledo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Cohort

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Amplitude (mV)
Compare preoperative, perioperative and postoperative amplitude changes from EMG
Latency (ms)
Compare preoperative, perioperative and postoperative latency changes from EMG
Velocity (m/s)
Compare preoperative, perioperative and postoperative velocity changes from EMG

Full Information

First Posted
August 20, 2015
Last Updated
September 21, 2017
Sponsor
University of Toledo Health Science Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02533024
Brief Title
Preoperative Prevalence of Ulnar Neuropathy and Changes in Ulnar Nerve Latency During Surgery
Official Title
Preoperative Prevalence of Ulnar Neuropathy and Changes in Ulnar Nerve Latency During Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Neuropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Cohort
Arm Type
Experimental
Arm Description
All subjects will have nerve conduction studies (Electromyography/EMG) pre-operatively, monitored intra-operatively and immediately post-operative.
Intervention Type
Other
Intervention Name(s)
Electromyography
Other Intervention Name(s)
EMG
Intervention Description
All subjects will have an EMG before, during and immediately after surgery.
Primary Outcome Measure Information:
Title
Prevalence of ulnar neuropathy in patients scheduled to undergo anesthesia and surgery as measured by electromyography
Description
Prevalence of undiagnosed or subclinical ulnar neuropathy as determined by electromyography
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Amplitude (mV)
Description
Compare preoperative, perioperative and postoperative amplitude changes from EMG
Time Frame
Day 1
Title
Latency (ms)
Description
Compare preoperative, perioperative and postoperative latency changes from EMG
Time Frame
Day 1
Title
Velocity (m/s)
Description
Compare preoperative, perioperative and postoperative velocity changes from EMG
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew B Casabianca, MD
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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