The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction

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Withdrawn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

    • Maryland
      • Fort Meade, Maryland, United States, 20755
        • Fort Meade

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
  • This represents conduction along the majority of the axons
  • It is recorded at the peak of the waveform response
1 day
Onset Latency
Time Frame: 1 day
  • This represents conduction along the fastest axons
  • It is recorded at the initial deflection from baseline
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

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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