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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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