Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block
NCT ID: NCT07302997
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
34 participants
INTERVENTIONAL
2025-12-31
2026-12-31
Brief Summary
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Participants will:
* be operated locally according to standard clinical practice
* undergo post-anesthesia recovery and any neurologic symptoms or signs assessment on postoperative days 1 and 7
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Smart Needle displaying
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure.
The anesthesiologist will use the real-time visual feedback to maintain a low injection pressure profile (i.e., not higher than 15 psi) and avoid pressure peaks. The anesthesiologist can immediately stop the injection if there is a sudden increase in pressure, reposition the needle and start again, while always maintaining a low injection pressure profile
Smart Needle Monitoring System
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure
Smart Needle flipped
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will be flipped allowing the recording of the injection pressure but not the real-time visualization by the anesthesiologist, who will perform the procedure as usual without a pressure visual feedback
Smart Needle Monitoring System
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure
Interventions
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Smart Needle Monitoring System
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Scheduled for elective surgery below the elbow (e.g., hand surgery, distal radius surgery, forearm surgery) requiring an axillary block
* ASA physical status I-III
* Ability to understand the investigation
* Ability and willingness to follow and complete the procedures of the investigation
Exclusion Criteria
* Refusal of locoregional anesthesia for the surgical procedure
* Pre-existing neurologic deficits in the operative extremity
* Body Mass Index ≥ 35 kg/m2
* Known allergy to local anesthetic (mepicavaine hydrochloride)
* Inability to comply with post-operative evaluations e.g. due to language problems, psychological disorders, dementia, etc. of the subject
18 Years
ALL
No
Sponsors
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Ente Ospedaliero Cantonale, Bellinzona
OTHER
Responsible Party
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Dossi Roberto
MD
Locations
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Ospedale Regionale di Bellinzona e Valli, EOC
Bellinzona, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Roberto Dossi, MD
Role: primary
Other Identifiers
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2025-D0048
Identifier Type: -
Identifier Source: org_study_id