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
About this trial
This is an interventional diagnostic trial for Ulnar Neuropathy
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
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
NCT ID
NCT02533024
First Posted
August 20, 2015
Last Updated
September 21, 2017
Sponsor
University of Toledo Health Science Campus
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
We'll reach out to this number within 24 hrs