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

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ClinicalTrials.gov Identifier: NCT04370184
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Prof Manoj K Karmakar, Chinese University of Hong Kong

Brief 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).

Condition or disease Intervention/treatment
Musculoskeletal Diseases or Conditions Procedure: Ultrasound guided Costoclavicular Brachial Plexus Block

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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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Ultrasound Imaging of the Brachial Plexus Sheath and Its Fascial Compartments at the Costoclavicular Space and Infraclavicular Fossa
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Procedure: Ultrasound 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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370184


Locations
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Hong Kong
Prince of Wales Hosptial
Shatin, New Territories, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Manoj K Karmakar, MD Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Manoj K Karmakar, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04370184    
Other Study ID Numbers: HD BPS Protocol Version 1
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Diseases