- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01716078
The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction
January 28, 2016 updated by: Defense and Veterans Center for Integrative Pain Management
The purpose of this study is to determine the conducting ability of distal extremity nerves after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed at a more proximal location in the upper extremity.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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
-
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Maryland
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Fort Meade, Maryland, United States, 20755
- Fort Meade
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male and female military health care beneficiaries age 18 years and older presenting for hand surgery and eligible for a brachial plexus nerve block will be asked to participate in this study.
Description
Inclusion Criteria:
- Male and female military health care beneficiaries 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy
- Written informed consent must be obtained from each patient prior to entering the study
- Patients must be willing to have a regional anesthetic nerve block placed prior to their scheduled procedure
- Patients must be willing to have neurodiagnostic tests performed prior to placement and after placement of the regional anesthesia nerve block
Exclusion Criteria:
- Refusal to have a brachial plexus nerve block placed
- Refusal to have serial nerve conduction studies performed
- Contraindication for a regional anesthesia nerve block (allergy to local anesthetic, infection at site of injection, elevated coagulation time)
- Presence of conditions affecting the hand or arm (e.g., injury, infection) that might preclude the performance of nerve conduction studies
- Presence of known major abnormalities of nerve conduction, e.g., absent median sensory potential in a patient scheduled for carpal tunnel release
- Presence of conditions affecting the contralateral hand or arm (e.g., injury, infection) that might preclude the performance of sensory and motor studies to test block or absence of a contralateral upper extremity
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compund Muscle Action Potential (CMAP) amplitude
Time Frame: 1 day
|
measured for motor studies from baseline to peak in mV
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distal Latency
Time Frame: 1 day
|
the interval between the stimulation of a compound muscle and the observed response.
Normal nerve conduction velocity is above 40 m/sec in the lower extremities and above 50 m/sec in the upper extremities, but age, muscle disease, temperature, and other factors can influence the velocity.
|
1 day
|
Peak Latency
Time Frame: 1 day
|
|
1 day
|
Onset Latency
Time Frame: 1 day
|
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
November 1, 2011
Primary Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
October 17, 2012
First Submitted That Met QC Criteria
October 25, 2012
First Posted (Estimate)
October 29, 2012
Study Record Updates
Last Update Posted (Estimate)
January 29, 2016
Last Update Submitted That Met QC Criteria
January 28, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 365681-8
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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