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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05409807
Enrollment
60
Registered
2022-06-08
Start date
2023-01-30
Completion date
2023-06-30
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Block

Keywords

Interscalene Block, Smart Glasses, Wearable Technology

Brief summary

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

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.

Interventions

DEVICEUltrasound guided smart glasses assisted

Ultrasound guided smart glasses assisted interscalene nerve block

DEVICEUltrasound guided

Ultrasound guided interscalene nerve block

Sponsors

Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First attempt success rateDuring peripheral nerve block procedure. Not to exceed 20 minutesUltrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached

Secondary

MeasureTime frameDescription
Ultrasound image timeDuring peripheral nerve block procedure. Not to exceed 20 minutesFrom ultrasound probe application, to get nerves image on the ultrasound screen
Nerve block timeDuring peripheral nerve block procedure. Not to exceed 20 minutesFrom needle puncture, to local anesthetic spreading
Overall attemptDuring peripheral nerve block procedure. Not to exceed 20 minutesNumber of attempt of needling
Operator's satisfactionDuring peripheral nerve block procedure. Not to exceed 20 minutesOperator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)
Complication rateThrough study completion, an average of 2 weekBlock failure, pneumothorax, hematoma, local anesthetic toxicity
Overall success rateDuring peripheral nerve block procedure. Up to 1 dayThe sensory and motor effect of the block

Countries

Turkey (Türkiye)

Contacts

Primary ContactIlker Ital, MD
ilkerital@gmail.com(0374) 253 46 56
Backup ContactTacettin Ayanoglu, MD
drtacettin@gmail.com(0374) 253 46 56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026