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CompletedNCT04370184Updated Jan 27, 2021

USG Imaging of Brachial Plexus Sheath & Its Fascial Compartments at Costoclavicular Space & Infraclavicular Fossa

An observational study in Musculoskeletal Diseases or Conditions, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Chinese University of Hong Kong · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Musculoskeletal Diseases or Conditions
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In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's enrollment of 100 is below the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • > 70 years old, BMI >30, ASA physical status > III, and with previous history surgery over the infraclavicular fossa
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • ProcedureUltrasound guided Costoclavicular Brachial Plexus Block

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day (will be reviewed once)

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Study locations

1 site
  • Prince of Wales Hosptial
    Shatin, New Territories, Hong Kong
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04370184
Lead sponsor
Chinese University of Hong Kong
Responsible party
Prof Manoj K Karmakar (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Apr 30, 2020
Start date
Jun 1, 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Jan 27, 2021

Study contacts

Manoj K Karmakar, MD
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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