Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks
- Conditions
- Nerve Block
- Interventions
- Device: Ultrasound guidedDevice: Ultrasound guided smart glasses assisted
- Registration Number
- NCT05409807
- Lead Sponsor
- Abant Izzet Baysal University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients who are planned to undergo surgery under general anesthesia
- Patients scheduled for postoperative analgesia after shoulder surgery
- Local anesthetic allergy
- Skin disease, infection, hematoma
- Chronic obstructive pulmonary disease
- Hepatic, renal, cardiac failures
- Pregnancy
- Uncooperative patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Classic Ultrasound Guided Ultrasound guided Ultrasound guided interscalene nerve block Smart Glasses Assisted Ultrasound guided smart glasses assisted Ultrasound guided smart glasses assisted interscalene nerve block
- Primary Outcome Measures
Name Time Method First attempt success rate During peripheral nerve block procedure. Not to exceed 20 minutes Ultrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached
- Secondary Outcome Measures
Name Time Method Overall attempt During peripheral nerve block procedure. Not to exceed 20 minutes Number of attempt of needling
Ultrasound image time During peripheral nerve block procedure. Not to exceed 20 minutes From ultrasound probe application, to get nerves image on the ultrasound screen
Nerve block time During peripheral nerve block procedure. Not to exceed 20 minutes From needle puncture, to local anesthetic spreading
Overall success rate During peripheral nerve block procedure. Up to 1 day The sensory and motor effect of the block
Operator's satisfaction During peripheral nerve block procedure. Not to exceed 20 minutes Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)
Complication rate Through study completion, an average of 2 week Block failure, pneumothorax, hematoma, local anesthetic toxicity
Trial Locations
- Locations (1)
Bolu Abant İzzet Baysal University Faculty of Medicine
🇹🇷Bolu, Turkey