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Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks

Primary Purpose

Arm Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Simulator
Cadaver
Sponsored by
Fundación Universitaria de Ciencias de la Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arm Injuries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Anesthesia residents

Exclusion Criteria:

  • Previous training in regional anesthesia techniques

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Simulator

    Cadaver

    Arm Description

    One training session with the simulator.

    One training session with a cadaver.

    Outcomes

    Primary Outcome Measures

    Time to locate axillary nerve in a cadaver

    Secondary Outcome Measures

    Time to identify axillary nerve in a cadaver

    Full Information

    First Posted
    November 6, 2013
    Last Updated
    November 12, 2013
    Sponsor
    Fundación Universitaria de Ciencias de la Salud
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01982305
    Brief Title
    Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks
    Official Title
    Simulator Versus Cadaver Training to Perform Ultrasound-guided Axillary Nerve Bocks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación Universitaria de Ciencias de la Salud

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique.
    Detailed Description
    Ultrasound-guided nerve blocks are becoming the standard of care in patients requiring regional anesthesia. Cost-effective training is needed for the implementation of these techniques in the global anesthesia practice. Existing simulators are expensive and not available in low income countries. The investigators aimed to test an inexpensive simulator for the training in this technique.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arm Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Simulator
    Arm Type
    Experimental
    Arm Description
    One training session with the simulator.
    Arm Title
    Cadaver
    Arm Type
    Active Comparator
    Arm Description
    One training session with a cadaver.
    Intervention Type
    Procedure
    Intervention Name(s)
    Simulator
    Intervention Description
    Axillary nerve anatomy lecture plus training with the simulator.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cadaver
    Intervention Description
    Axillary nerve anatomy lecture plus training with the cadaver model.
    Primary Outcome Measure Information:
    Title
    Time to locate axillary nerve in a cadaver
    Time Frame
    At the end of the procedure, expected average of 30 seconds
    Secondary Outcome Measure Information:
    Title
    Time to identify axillary nerve in a cadaver
    Time Frame
    During the procedure, expected average of 15 seconds

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Anesthesia residents Exclusion Criteria: Previous training in regional anesthesia techniques
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luis E Reyes, MD
    Organizational Affiliation
    Fundacion Universitaria de Ciencias de la Salud
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Luis A Muñoz, MD
    Organizational Affiliation
    Fundacion Universitaria de Ciencias de la Salud
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks

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