High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove

High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove: A Prospective Observational Volunteer Study

This study aims to define the intermuscular bridges between the scalene muscles at the interscalene groove (around neck area) using high definition US imaging in a cohort of volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Ultrasound scan

Detailed Description

The Interscalene brachial plexus block (ISBPB), with recent techniques like phrenic nerve sparing interscalene approach, has better safety profile than before and because of this, it is often the technique of choice for anaesthesia and/or analgesia during shoulder and proximal arm surgery. Anatomical variations at the interscalene groove are not uncommon and few have been described in the literature. Understanding the anatomy of the brachial plexus and its sheath at the interscalene groove is vital for the success of the block and to reduce the risk of complications during ultrasound (US) guided ISBPB. Recently, with the use of high definition ultrasound, using high frequency linear transducer, the principal investigator have identified intermuscular bridges appearing between the ventral rami of the brachial plexus at the interscalene groove. These intermuscular bridges may affect the spread of local anesthetic dispersion within the brachial plexus sheath thereby affecting the block dynamics of ISBPB. Therefore, this prospective observational study aim to define the intermuscular bridges at the interscalene groove using high definition ultrasound imaging in a group of healthy volunteers.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon
    • Shatin, Kowloon, Hong Kong
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult volunteers among staff, residents and their friends

Description

Inclusion Criteria:

• volunteers consented for the scanning

Exclusion Criteria:

• prior surgery on either side of the neck
• presence of obvious deformity

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the interscalene muscular ridges	Volunteers will have ultrasound (USG) scanning of both sides of their necks that last for 20 minutes. Images will be recorded as video loops of 7 seconds each that include supraclavicular fossa, C5-7 transverse processes, superior, middle and inferior trunk. After completion of all scannings, newly coded video loops not in a predetermined order or sequence, will be assessed by 3 senior anaesthesiologists and the visualization of the intermuscular bridges at the interscalene groove will be noted. The quality of ultrasound visibility (ultrasound visibility score, UVS) of each structure will be assessed using a 4-point Likert scale (0, not visible; 1, hardly visible; 2, well visible; 3, very well visible). Total UVS (maximum score possible=15) will be calculated by averaging the scores from the three outcome assessors. The percentage of agreement among 3 outcome assessors will be determined by using data on positive identification of the interscalene muscular ridges.	through study completion, an average of 20 minutes.

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: interscalene groove; intermuscular bridges
• Other Study ID Numbers: Intersca Vol Scan 2020.356

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No