In-plane Ultrasound-guided Regional Anesthesia PerformanceNCT01690156
Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks
An observational study of In-plane Ultrasound-guided Regional Anesthesia Performance, run by University of New Mexico at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- In-plane Ultrasound-guided Regional Anesthesia Performance
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers naiive to ultrasound techniques
Who may be able to join
- Healthy volunteers
- Right handed
- Aged 18 to 55
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87120
About this study
Official title: 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.
Read the 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.
- Keywords
- In-plane, Ultrasound-guided regional anesthesia performance, Probe position, Needle visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parallel Probe Position | Performing the simulated interscalene block with the ultrasound probe parallel to the shoulders of the person performing the block | |
| Perpendicular Probe Position | Performing the simulated interscalene block with the ultrasound probe perpendicular to the shoulders of the person performing the block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to perform a simulated interscalene block
Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets
Measured: 1 hour
Secondary outcomes (1)
Duration where the entire needle is not visualized when performing the simulated interscalene block
Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: This is not a clinical trial and was inadvertently entered in the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-plane Ultrasound-guided Regional Anesthesia PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas C Lam, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690156
- Sponsor's protocol ID
- Probeposition
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2012
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Control Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks
- ClinicalTrials.gov ID
- NCT01690156
- Acronym / sponsor ID
- Probeposition
- Keywords
- In-plane, Ultrasound-guided regional anesthesia performance, Probe position, Needle visualization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is not a clinical trial and was inadvertently entered in the system.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parallel Probe Position | – | –Performing the simulated interscalene block with the ultrasound probe parallel to the shoulders of the person performing the block |
| Perpendicular Probe Position | – | –Performing the simulated interscalene block with the ultrasound probe perpendicular to the shoulders of the person performing the block |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers naiive to ultrasound techniques
Key inclusion criteria (3 listed)
- Healthy volunteers
- Right handed
- Aged 18 to 55
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time taken to perform a 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 secondary outcome
Duration where the entire needle is not visualized when performing the simulated interscalene block
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: This is not a clinical trial and was inadvertently entered in the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas C Lam, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-plane Ultrasound-guided Regional Anesthesia Performance, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This is not a clinical trial and was inadvertently entered in the system.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to perform a simulated interscalene block (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.