We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716078
First Posted: October 29, 2012
Last Update Posted: January 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management
  Purpose
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.

Condition
Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction

Further study details as provided by Defense and Veterans Center for Integrative Pain Management:

Primary Outcome Measures:
  • Compund Muscle Action Potential (CMAP) amplitude [ Time Frame: 1 day ]
    measured for motor studies from baseline to peak in mV


Secondary Outcome Measures:
  • 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.

  • 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

  • Onset Latency [ Time Frame: 1 day ]
    • This represents conduction along the fastest axons
    • It is recorded at the initial deflection from baseline


Enrollment: 0
Study Start Date: November 2011
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716078


Locations
United States, Maryland
Fort Meade
Fort Meade, Maryland, United States, 20755
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
  More Information

Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT01716078     History of Changes
Other Study ID Numbers: 365681-8
First Submitted: October 17, 2012
First Posted: October 29, 2012
Last Update Posted: January 29, 2016
Last Verified: January 2016

Keywords provided by Defense and Veterans Center for Integrative Pain Management:
Brachial Plexus
Nerve Block
Nerve Conduction