NCT04370184

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

April 29, 2020

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

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.

    1 day (will be reviewed once)

Interventions

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hosptial

Shatin, New Territories, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Manoj K Karmakar, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2020

First Posted

April 30, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations