- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690156
Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks
January 8, 2024 updated by: University of New Mexico
Double Blinded Randomized Control Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks
Ultrasound has been used to guide a needle to inject local anesthetics around nerves.
This is usually done in the same plane as the ultrasound beam in America and is known as an in-plane technique.
When done correctly, the entire needle is visualized on the ultrasound screen as it approaches the nerves which are also seen on the same screen the entire time.
The ultrasound probe can be held perpendicular or parallel to the shoulders of the person performing the in-plane technique.
Our hypothesis is that holding the ultrasound probe perpendicular to the shoulder is superior to holding the probe parallel to the shoulder during an in-plane ultrasound guided regional anesthesia technique.
Study Overview
Status
Terminated
Detailed Description
Right handed volunteers with no prior exposure to ultrasound techniques are used in this study.
They will be randomly assigned to be shown an instructional video on how to perform an in-plane ultrasound guided needling technique on a realistic simulation target.
The two videos are identical with the exception of the probe position.
A blinded assessor will time the volunteers performance behind a screen and note the duration in which the needle is not visualized in the ultrasound screen.
Study Type
Observational
Enrollment (Actual)
62
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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New Mexico
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Albuquerque, New Mexico, United States, 87120
- University of New Mexico
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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 to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers naiive to ultrasound techniques
Description
Inclusion Criteria:
- Healthy volunteers
- Right handed
- Aged 18 to 55
Exclusion Criteria:
- Any person who has prior knowledge about ultrasound imaging or regional anesthesia
- Any person who has prior experience with laparoscopy or biopsy
- Any person who has problems with depth of field or simple hand eye co-ordination task
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
Cohorts and Interventions
Group / Cohort |
|---|
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Parallel Probe Position
Performing the simulated interscalene block with the ultrasound probe parallel to the shoulders of the person performing the block
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Perpendicular Probe Position
Performing the simulated interscalene block with the ultrasound probe perpendicular to the shoulders of the person performing the block
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time taken to perform a simulated interscalene block
Time Frame: 1 hour
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Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets
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1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration where the entire needle is not visualized when performing the simulated interscalene block
Time Frame: 1 hour
|
Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicholas C Lam, MD, University of New Mexico
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 (Actual)
August 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
September 17, 2012
First Submitted That Met QC Criteria
September 20, 2012
First Posted (Estimated)
September 21, 2012
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 8, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Probeposition
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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