Paraneural Sheath & Fascial Compartments Surround Brachial Plexus at Supraclavicular Fossa During Selective Trunk Block
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
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2021
CompletedNovember 15, 2021
November 1, 2021
2 months
August 31, 2021
November 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visualization of anatomical nerve structures
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 Outcomes (2)
Visualization of the presence of anatomical variations
through study completion, an average of 1 month
Presence of artery within the nerve cluster
through study completion, an average of 1 month
Interventions
High definition ultrasound images that were acquired during USG SeTB are routinely stored in the hard disk of ultrasound machine in DICOM (Digital Imaging and Communications in Medicine) format will be used for this review. The images of principal investigator's previous research studies with Clinical trial registration: NCT04752410 and NCT04773405 will also be retrieved. The ultrasound imaging was performed before (scout scan), during and immediately after the USG SeTB. As is the principal investigator's standard practice, all ultrasound scan was performed in a sequential manner (SUIT: Sequential Ultrasound Imaging Technique) with the orientation marker of the transducer directed laterally so as to obtain a transverse oblique view of the brachial plexus block at the supraclavicular fossa. Approximate 50 cases who had undergone USG SeTB for surgical anesthesia during upper extremity surgery since January 1 2020 to June 30, 2021 will be evaluated by two anesthesiologists.
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- patients \> 75 years old
- American Society of Anesthesiologists (ASA) physical status \> Ⅲ
- previous history of surgery at ipsilateral neck.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
Shatin, New Territories, Hong Kong
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manoj K Karmakar, MD
Chinese University of Hong Kong
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 16, 2021
Study Start
September 20, 2021
Primary Completion
November 12, 2021
Study Completion
November 12, 2021
Last Updated
November 15, 2021
Record last verified: 2021-11