- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05045300
Paraneural Sheath & Fascial Compartments Surround Brachial Plexus at Supraclavicular Fossa During Selective Trunk Block
November 11, 2021 updated by: Prof Manoj K Karmakar, Chinese University of Hong Kong
Paraneural Sheath and Fascial Compartments Surrounding the Brachial Plexus at the Supraclavicular Fossa: A Retrospective Review of High Definition Ultrasound Images Acquired During Selective Trunk Brachial Plexus Blockade
The aim of this retrospective study is to define the paraneural (fascial) sheath and fascial compartments that surround the brachial plexus at the supraclavicular fossa by reviewing previous ultrasound images from cases that have undergone ultrasound guided selective trunk brachial plexus block.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The optimal anatomical plane (relative to the nerve) or the "goal" for local anesthetic (LA) injection during an ultrasound guided (USG) brachial plexus blockade (BPB) at the supraclavicular fossa is currently not known.
USG BPB is often described as a "subfascial", "extra fascial", "intracluster", "interfascial", sub-perineural", "intraneural", "corner pocket" or "periplexus" injection.
Although this suggests that the local anesthetic is injected into different tissue planes or fascial compartments, even if such planes do exist, as seen in other regions such as popliteal sciatic nerve are not clearly defined at the supraclavicular fossa.
However, recently with the use of high definition ultrasound imaging for USG Selective trunk block (SeTB) and principal investigator has often observed distinct paraneural (fascial) sheath and fascial compartments surrounding the brachial plexus at the supraclavicular fossa.
These connective tissue layers are also better delineated after the local anesthetic injection.
The principal investigator believes these may be the connective tissue layers that previous researchers have referred to in different reports.
Currently there are no published data demonstrating the paraneural sheath and fascial compartment surrounding the brachial plexus in-vivo.
Principal investigator believes that this fascial layer and compartment influence the spread of LA during USG BPB around the individual elements of the brachial plexus at the supraclavicular fossa and therefore, these anatomical structures have to be delineated so as to improve the safety, success and quality of USG BPB.
This study will involve reviewing archived high definition ultrasound images in audio video interleave format from all adult patients who had undergone USG SeTB for surgical anesthesia during upper extremity surgery from January 1, 2020 to June 30, 2021 to define the paraneural sheath and fascial compartments that surround the brachial plexus at the supraclavicular fossa.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Territories
-
Shatin, New Territories, Hong Kong
- Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Dataset of previous research titled "Selective Trunk Block: A Prospective Non-Randomized Study of Intervention" (approved by the Joint CUHK-NTEC CREC; CREC Ref no: 2020.687-T;
Clinical trial registration: NCT04752410) and " Minimum Effective Local Anaesthetic Volume of a 1:1 Mixture of 2% Lidocaine with 5 µg/ml of Epinephrine and 0.5% Levobupivacaine Required for Ultrasound Guided Selective Trunk Block: A Dose Finding Study" (approved by the Joint CUHK-NTEC CREC; CREC Ref no:2020.680-T;
Clinical trial registration: NCT04773405) will also be retrieved.
Description
Inclusion Criteria:
- Archived high definition ultrasound images (datasets) in audio video interleave (AVI) format from all adult patients who had undergone ultrasound guided selective trunk block for surgical anesthesia during upper extremity surgery since the year 2020 (from 01/01/2020 to 30/06/2021).
Exclusion Criteria:
- patients > 75 years old
- American Society of Anesthesiologists (ASA) physical status > Ⅲ
- previous history of surgery at ipsilateral neck.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visualization of anatomical nerve structures
Time Frame: through study completion, an average of 1 month
|
Two anesthesiologists with extensive experience in regional anesthesia and familiar with the fascial anatomy of the brachial plexus at the supraclavicular fossa will independently review the archived ultrasound images and compare the presence of anatomical nerve structures before and after local anesthetic injection.
The structure viewed will be scored as 0=no, 1= yes.
If a structure is visualized then a previously reported four-point numerical scale, (0=not visible, 1= hardly visible, 2=well visible, 3= very well visible_ will be used to assess the quality of ultrasound visibility.
The total ultrasound visibility score (UVS) of the anatomical structures in the transverse scan will be calculated for every subject (maximum score possible = 30) and the mean total UVS will be determined by averaging the scores of the two observers.
Inter-rater agreement of the aforementioned anatomical structures between the anesthesiologist will be calculated using kappa statistics.
|
through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visualization of the presence of anatomical variations
Time Frame: through study completion, an average of 1 month
|
Two anesthesiologists with extensive experience in regional anesthesia and familiar with the fascial anatomy of the brachial plexus at the supraclavicular fossa will independently review the archived ultrasound images and compare the presence of anatomical variations before and after local anesthetic agent injection.
It will be scored as 0=not presence, 1=presence.
|
through study completion, an average of 1 month
|
|
Presence of artery within the nerve cluster
Time Frame: through study completion, an average of 1 month
|
Two anesthesiologists with extensive experience in regional anesthesia and familiar with the fascial anatomy of the brachial plexus at the supraclavicular fossa will independently review the archived ultrasound images and evaluate the presence or absence of blood vessels inside the nerve cluster at the supraclavicular fossa.
A score of 0=not presence and 1=presence.
|
through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2021
Primary Completion (Actual)
November 12, 2021
Study Completion (Actual)
November 12, 2021
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
September 6, 2021
First Posted (Actual)
September 16, 2021
Study Record Updates
Last Update Posted (Actual)
November 15, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE.2021.474
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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