High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove
June 17, 2021 updated by: Prof Manoj K Karmakar, Chinese University of Hong Kong
High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove: A Prospective Observational Volunteer Study
This study aims to define the intermuscular bridges between the scalene muscles at the interscalene groove (around neck area) using high definition US imaging in a cohort of volunteers.
Study Overview
Detailed Description
The Interscalene brachial plexus block (ISBPB), with recent techniques like phrenic nerve sparing interscalene approach, has better safety profile than before and because of this, it is often the technique of choice for anaesthesia and/or analgesia during shoulder and proximal arm surgery.
Anatomical variations at the interscalene groove are not uncommon and few have been described in the literature.
Understanding the anatomy of the brachial plexus and its sheath at the interscalene groove is vital for the success of the block and to reduce the risk of complications during ultrasound (US) guided ISBPB.
Recently, with the use of high definition ultrasound, using high frequency linear transducer, the principal investigator have identified intermuscular bridges appearing between the ventral rami of the brachial plexus at the interscalene groove.
These intermuscular bridges may affect the spread of local anesthetic dispersion within the brachial plexus sheath thereby affecting the block dynamics of ISBPB.
Therefore, this prospective observational study aim to define the intermuscular bridges at the interscalene groove using high definition ultrasound imaging in a group of healthy volunteers.
Study Type
Observational
Enrollment (Actual)
50
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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Kowloon
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Shatin, Kowloon, Hong Kong
- Prince of Wales Hospital
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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 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult volunteers among staff, residents and their friends
Description
Inclusion Criteria:
- volunteers consented for the scanning
Exclusion Criteria:
- prior surgery on either side of the neck
- presence of obvious deformity
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Identification of the interscalene muscular ridges
Time Frame: through study completion, an average of 20 minutes.
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Volunteers will have ultrasound (USG) scanning of both sides of their necks that last for 20 minutes.
Images will be recorded as video loops of 7 seconds each that include supraclavicular fossa, C5-7 transverse processes, superior, middle and inferior trunk.
After completion of all scannings, newly coded video loops not in a predetermined order or sequence, will be assessed by 3 senior anaesthesiologists and the visualization of the intermuscular bridges at the interscalene groove will be noted.
The quality of ultrasound visibility (ultrasound visibility score, UVS) of each structure will be assessed using a 4-point Likert scale (0, not visible; 1, hardly visible; 2, well visible; 3, very well visible).
Total UVS (maximum score possible=15) will be calculated by averaging the scores from the three outcome assessors.
The percentage of agreement among 3 outcome assessors will be determined by using data on positive identification of the interscalene muscular ridges.
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through study completion, an average of 20 minutes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 23, 2020
Primary Completion (ACTUAL)
December 31, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
September 7, 2020
First Submitted That Met QC Criteria
September 7, 2020
First Posted (ACTUAL)
September 14, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 18, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Intersca Vol Scan 2020.356
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.