Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks

May 4, 2023 updated by: Ilker Ital, Abant Izzet Baysal University

Comparison of Classical Ultrasound Guided Method and Combined Wearable Display Technology Method With Ultrasound in Interscalene Nerve Block Applied in Shoulder Surgery

This study hypothesizes that the use of smart glasses (Head-mounted display Vufine, model VUF-110, Vufine Inc., China)) improves the hand-eye coordination and the first-attempt success rate of ultrasound guided interscalene nerve block. This is a single-center, randomized, controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the interscalene block.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Peripheral nerve blocks, which help patients to recover early after surgery, are performed safely and successfully under ultrasound guidance. Ultrasound-guided peripheral nerve blocks provide sufficient anesthesia for the operation alone or can be applied in combination with general anesthesia and provide postoperative analgesia.

Investigators encounter new developments in health technologies almost every day. With the development of smart technologies and the spread of wearable devices, their use in the field of health is increasing day by day.

Hand-eye coordination is an important skill, especially in the use of ultrasound. The inserted needle should be followed during the procedure in the appropriate area and safely delivered to the desired area.

Patients will be divided into either the study group or the control group. Interscalene nerve block will be performed with preoperative sedation, ultrasound guidance and nerve stimulator.

Interscalene nerve block will be applied to the patients in the study group by using the smart glasses screen, and to the patients in the control group with the conventional ultrasound screen.

In this clinical study, the first trial success rate of the procedures, the time spent during the procedure, the overall success rate, the ergonomics of the practitioner, and the complications related to the block will be recorded and compared.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Bolu, Turkey, 14030
        • Recruiting
        • Bolu Abant İzzet Baysal University Faculty of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kasım İlker İtal, MD

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are planned to undergo surgery under general anesthesia
  • Patients scheduled for postoperative analgesia after shoulder surgery

Exclusion Criteria:

  • Local anesthetic allergy
  • Skin disease, infection, hematoma
  • Chronic obstructive pulmonary disease
  • Hepatic, renal, cardiac failures
  • Pregnancy
  • Uncooperative patient

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Classic Ultrasound Guided
Ultrasound guided interscalene nerve block
Device: Ultrasound guided
Ultrasound guided interscalene nerve block
Experimental: Smart Glasses Assisted
Ultrasound guided smart glasses assisted interscalene nerve block
Device: Ultrasound guided smart glasses assisted
Ultrasound guided smart glasses assisted interscalene nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First attempt success rate
Time Frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Ultrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached
During peripheral nerve block procedure. Not to exceed 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall attempt
Time Frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Number of attempt of needling
During peripheral nerve block procedure. Not to exceed 20 minutes
Ultrasound image time
Time Frame: During peripheral nerve block procedure. Not to exceed 20 minutes
From ultrasound probe application, to get nerves image on the ultrasound screen
During peripheral nerve block procedure. Not to exceed 20 minutes
Nerve block time
Time Frame: During peripheral nerve block procedure. Not to exceed 20 minutes
From needle puncture, to local anesthetic spreading
During peripheral nerve block procedure. Not to exceed 20 minutes
Overall success rate
Time Frame: During peripheral nerve block procedure. Up to 1 day
The sensory and motor effect of the block
During peripheral nerve block procedure. Up to 1 day
Operator's satisfaction
Time Frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)
During peripheral nerve block procedure. Not to exceed 20 minutes
Complication rate
Time Frame: Through study completion, an average of 2 week
Block failure, pneumothorax, hematoma, local anesthetic toxicity
Through study completion, an average of 2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Principal Investigator: Ilker Ital, MD, Bolu Abant İzzet Baysal Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 30, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 8, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AIBU-TF-AR-II-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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