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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nerve Block

Intervention / Treatment
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* Device: Ultrasound guided smart glasses assisted
* Device: Ultrasound guided


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Classic Ultrasound Guided<br>Ultrasound guided interscalene nerve block | Device: Ultrasound guided<br>* Ultrasound guided interscalene nerve block<br>|
| Experimental: Smart Glasses Assisted<br>Ultrasound guided smart glasses assisted interscalene nerve block | Device: Ultrasound guided smart glasses assisted<br>* Ultrasound guided smart glasses assisted interscalene nerve block<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interscalene Block, Smart Glasses, Wearable Technology