HealthyNCT04547270
High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove
An observational study of Healthy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ultrasound scan
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Sep 2020to 31 Dec 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult volunteers among staff, residents and their friends
Who may be able to join
- volunteers consented for the scanning
Who cannot join
- prior surgery on either side of the neck
- presence of obvious deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ultrasound scan
- Keywords
- interscalene groove, intermuscular bridges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanOther
Volunteers will have an ultrasound scanning of both sides of their neck lying in supine position. Sequentially the scanning will start from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. Images will be recorded as video loops.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the interscalene muscular ridges
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.
Measured: through study completion, an average of 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start23 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Manoj K Karmakar, Chinese University of Hong Kong
- Investigators
- Manoj K Karmakar, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547270
- Sponsor's protocol ID
- Intersca Vol Scan 2020.356
- Status last verified
- Jun 2021
- First submitted
- 7 Sep 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove: A Prospective Observational Volunteer Study
- ClinicalTrials.gov ID
- NCT04547270
- Acronym / sponsor ID
- Intersca Vol Scan 2020.356
- Conditions
- Healthy
- Keywords
- interscalene groove, intermuscular bridges
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Sep 2020 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult volunteers among staff, residents and their friends
Key inclusion criteria (1 listed)
- volunteers consented for the scanning
Key exclusion criteria (2 listed)
- prior surgery on either side of the neck
- presence of obvious deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound scanVolunteers will have an ultrasound scanning of both sides of their neck lying in supine position. Sequentially the scanning will start from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. Images will be recorded as video loops. | Other | – |
Primary outcome
Identification of the interscalene muscular ridges
Time frame: through study completion, an average of 20 minutes.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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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.
Manoj K Karmakar, MD principal investigator
Chinese University of Hong Kong
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 Healthy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jun 2021. 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 Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification of the interscalene muscular ridges (time frame: through study completion, an average of 20 minutes.). 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 18 Jun 2021.