Musculoskeletal Diseases or ConditionsNCT04370184
USG Imaging of Brachial Plexus Sheath & Its Fascial Compartments at Costoclavicular Space & Infraclavicular Fossa
An observational study of Musculoskeletal Diseases or Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The existence of the brachial plexus sheath (BPS) and its septae and compartments has been a subject of debate and controversy. Numerous cadaver studies indicate that BPS is present while other researchers based on limited clinical data suggest none. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Ultrasound guided Costoclavicular Brachial Plexus Block
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 adult patients who had undergone ultrasound guided costoclavicular brachial plexus block for surgical anesthesia during forearm or hand surgery over a 5 year period, from April 2013 to April 2018.
Who may be able to join
- Archived high definition ultrasound images (datasets) as multiple short video loop (6 seconds) in avi format from 100 adult patients who had undergone ultrasound guided costoclavicular brachial plexus block for surgical anesthesia during forearm or hand surgery, over a 5 year period, from April 2013 to April 2018 will be retrieved for review.
Who cannot join
- > 70 years old, BMI >30, ASA physical status > III, and with previous history surgery over the infraclavicular fossa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Imaging of the Brachial Plexus Sheath and Its Fascial Compartments at the Costoclavicular Space and Infraclavicular Fossa
The existence of the brachial plexus sheath (BPS) and its septae and compartments has been a subject of debate and controversy. Numerous cadaver studies indicate that BPS is present while other researchers based on limited clinical data suggest none. Nevertheless, cumulative evidence over the last six decades indicate that it is multi-layered, fibrous and a web-like connective tissue that is derived from the deep cervical fascia and fused with the deep fascia of the arm The BPS completely envelopes that neurovascular bundle and filed with loose connective tissue and fat. It is a multi-compartment structure in the axilla with each nerve having a separate compartment, that communicate with each other. Some studies suggested that the septae affect the spread of local anesthetic during an axillary or infraclavicular brachial plexus block, while some suggest the opposite. With the use of ultrasound imaging, researchers found the presence of this connective tissue septum within the BPS at the costoclavicular space and infraclavicular fossa. The septum is visualized as a linear hyperechoic band on ultrasound imaging and when present appears to reduce the spread of the drugs during brachial plexus block. Yet the anatomy is poorly seen with the previous generation of ultrasound imaging. The aim of this study is to define the connective tissue (fascial) layers that surround the brachial plexus and its septum at the infraclavicular fossa by reviewing our archived high definition ultrasound images of 100 patients who had successfully undergone the ultrasound guided brachial plexus block over a 5 year period (2013 to 2018).
Read the detailed description
This is a retrospective study reviewing archived high definition ultrasound images as multiple short video loops (6 seconds) in avi format from 100 adult patients who had undergone ultrasound guided costoclavicular brachial plexus block for surgical anesthesia for their upper limb surgery over a 5 year period, from April 2013 to April 2018 by three experienced anesthesiologists. Demographics data such as age, gender, body mass index, ASA Physical Classification System, local anesthetic drug used and mode of anesthesia can be retrieved from patients' record or Clinical Management System. No direct contact nor intervention will be done to the patients in this study, so waiver of patient informed consent has been sought. There will be no patients' data in any of the ultrasound images as the ultrasound video loops for the costoclavicular brachial plexus block are routinely saved anonymously for all patients. All information related to the patients will be kept confidential and they will not be identified in any form in future publications.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Ultrasound guided Costoclavicular Brachial Plexus Block
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Costoclavicular Brachial Plexus BlockProcedure or surgery
Ultrasound images from patients scheduled for upper limb surgery under costoclavicular brachial plexus block (one kind of regional anesthesia) have been routinely collected at our institute. These images will be reviewed.
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound visibility of the anatomical structures around the neck
Positive or negative ultrasound visibility (yes or no response) of a given anatomical structure (pectoralis major muscle, subclavius muscle, serratus anterior muscle, costoclavicular space, axillary artery, lateral, medial and posterior cords of the brachial plexus, brachial plexus space (BPS), septum within the BPS, and the anterior \& posterior compartment) will be agreed upon by consensus among the three outcome assessors. If a structure is visible the quality of ultrasound visibility will be assessed using a 4-point Likert scale (0=not visible, 1=hardly visible, 2=well visible, 3=very well visible). The total ultrasound visibility score (UVS, maximum score possible is 36 at the costoclavicular space and 33 at the lateral infraclavicular fossa will thereby computed.
Measured: 1 day (will be reviewed once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Diseases or ConditionsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 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
- NCT04370184
- Sponsor's protocol ID
- HD BPS Protocol Version 1
- Status last verified
- Jan 2021
- First submitted
- 29 Apr 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Areeruk P, Karmakar MK, Reina MA, Mok LYH, Sivakumar RK, Sala-Blanch X. High-definition ultrasound imaging defines the paraneural sheath and fascial compartments surrounding the cords of the brachial plexus at the costoclavicular space and lateral infraclavicular fossa. Reg Anesth Pain Med. 2021 Jun;46(6):500-506. doi: 10.1136/rapm-2020-102304. Epub 2021 Apr 2.
PubMed 33811182
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of the Brachial Plexus Sheath and Its Fascial Compartments at the Costoclavicular Space and Infraclavicular Fossa
- ClinicalTrials.gov ID
- NCT04370184
- Acronym / sponsor ID
- HD BPS Protocol Version 1
- Conditions
- Musculoskeletal Diseases or Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Apr 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.
The existence of the brachial plexus sheath (BPS) and its septae and compartments has been a subject of debate and controversy. Numerous cadaver studies indicate that BPS is present while other researchers based on limited clinical data suggest none. Nevertheless, cumulative evidence over the last six decades indicate that it is multi-layered, fibrous and a web-like connective tissue that is derived from the deep cervical fascia and fused with the deep fascia of the arm The BPS completely envelopes that neurovascular bundle and filed with loose connective tissue and fat. It is a multi-compartment structure in the axilla with each nerve having a separate compartment, that communicate with each other. Some studies suggested that the septae affect the spread of local anesthetic during an axillary or infraclavicular brachial plexus block, while some suggest the opposite. With the use of ultrasound imaging, researchers found the presence of this connective tissue septum within the BPS at the costoclavicular space and infraclavicular fossa. The septum is visualized as a linear hyperechoic band on ultrasound imaging and when present appears to reduce the spread of the drugs during brachial plexus block. Yet the anatomy is poorly seen with the previous generation of ultrasound imaging. The aim of this study is to define the connective tissue (fascial) layers that surround the brachial plexus and its septum at the infraclavicular fossa by reviewing our archived high definition ultrasound images of 100 patients who had successfully undergone the ultrasound guided brachial plexus block over a 5 year period (2013 to 2018).
Detailed description
This is a retrospective study reviewing archived high definition ultrasound images as multiple short video loops (6 seconds) in avi format from 100 adult patients who had undergone ultrasound guided costoclavicular brachial plexus block for surgical anesthesia for their upper limb surgery over a 5 year period, from April 2013 to April 2018 by three experienced anesthesiologists. Demographics data such as age, gender, body mass index, ASA Physical Classification System, local anesthetic drug used and mode of anesthesia can be retrieved from patients' record or Clinical Management System. No direct contact nor intervention will be done to the patients in this study, so waiver of patient informed consent has been sought. There will be no patients' data in any of the ultrasound images as the ultrasound video loops for the costoclavicular brachial plexus block are routinely saved anonymously for all patients. All information related to the patients will be kept confidential and they will not be identified in any form in future publications.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 adult patients who had undergone ultrasound guided costoclavicular brachial plexus block for surgical anesthesia during forearm or hand surgery over a 5 year period, from April 2013 to April 2018.
Key inclusion criteria (1 listed)
- Archived high definition ultrasound images (datasets) as multiple short video loop (6 seconds) in avi format from 100 adult patients who had undergone ultrasound guided costoclavicular brachial plexus block for surgical anesthesia during forearm or hand surgery, over a 5 year period, from April 2013 to April 2018 will be retrieved for review.
Key exclusion criteria (1 listed)
- > 70 years old, BMI >30, ASA physical status > III, and with previous history surgery over the infraclavicular fossa
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 guided Costoclavicular Brachial Plexus BlockUltrasound images from patients scheduled for upper limb surgery under costoclavicular brachial plexus block (one kind of regional anesthesia) have been routinely collected at our institute. These images will be reviewed. | Procedure or surgery | – |
Primary outcome
ultrasound visibility of the anatomical structures around the neck
Time frame: 1 day (will be reviewed once)
Positive or negative ultrasound visibility (yes or no response) of a given anatomical structure (pectoralis major muscle, subclavius muscle, serratus anterior muscle, costoclavicular space, axillary artery, lateral, medial and posterior cords of the brachial plexus, brachial plexus space (BPS), septum within the BPS, and the anterior \& posterior compartment) will be agreed upon by consensus among the three outcome assessors. If a structure is visible the quality of ultrasound visibility will be assessed using a 4-point Likert scale (0=not visible, 1=hardly visible, 2=well visible, 3=very well visible). The total ultrasound visibility score (UVS, maximum score possible is 36 at the costoclavicular space and 33 at the lateral infraclavicular fossa will thereby computed.
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 27 Jan 2021.
- Derived from this study: PubMed 33811182Areeruk P, Karmakar MK, Reina MA, Mok LYH, Sivakumar RK, Sala-Blanch X. High-definition ultrasound imaging defines the paraneural sheath and fascial compartments surrounding the cords of the brachial plexus at the costoclavicular space and lateral infraclavicular fossa. Reg Anesth Pain Med. 2021 Jun;46(6):500-506. doi: 10.1136/rapm-2020-102304. Epub 2021 Apr 2.
- Individual participant dataSharing planned: No
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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 Musculoskeletal Diseases or Conditions, 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 1 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 27 Jan 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?
ultrasound visibility of the anatomical structures around the neck (time frame: 1 day (will be reviewed once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370184, which also lists 1 linked publication.
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 27 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.