NCT05045300

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

August 31, 2021

Last Update Submit

November 11, 2021

Conditions

Keywords

Selective Trunk block

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.

Also known as: Ultrasound imaging

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Manoj K Karmakar, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

Locations