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

November 12, 2013 updated by: Fundación Universitaria de Ciencias de la Salud

Simulator Versus Cadaver Training to Perform Ultrasound-guided Axillary Nerve Bocks

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anesthesia residents

Exclusion Criteria:

  • Previous training in regional anesthesia techniques

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simulator
One training session with the simulator.
Procedure: Simulator
Axillary nerve anatomy lecture plus training with the simulator.
Active Comparator: Cadaver
One training session with a cadaver.
Procedure: Cadaver
Axillary nerve anatomy lecture plus training with the cadaver model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to locate axillary nerve in a cadaver
Time Frame: At the end of the procedure, expected average of 30 seconds
At the end of the procedure, expected average of 30 seconds

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to identify axillary nerve in a cadaver
Time Frame: During the procedure, expected average of 15 seconds
During the procedure, expected average of 15 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universitaria de Ciencias de la Salud

Investigators

  • Principal Investigator: Luis E Reyes, MD, Fundación Universitaria de Ciencias de la Salud
  • Principal Investigator: Luis A Muñoz, MD, Fundación Universitaria de Ciencias de la Salud

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

August 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acta No. 277 Aug 6, 2012

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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