Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block
A Single-Center, First-in-Human, Randomized, Controlled, Feasibility Study of a New Device for the Real-Time Continuous Monitoring of the Injection Pressure of Local Anesthetic in Subjects Undergoing Ultrasound-guided Peripheral Nerve Block: the Smart Needle Monitoring System Investigation
Ente Ospedaliero Cantonale, Bellinzona
34 participants
Dec 19, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial with medical device is to learn if the Smart Needle Monitoring System works to maintain a safe low injection pressure during a type of regional anaesthetic (Peripheral Nerve Block (PNB)) in patients due to undergo surgery below the elbow . It will also learn about the safety of the device and patients' perception of the quality of anesthesia. 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
Eligibility
Inclusion Criteria6
- Informed Consent signed by the subject
- 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 Criteria6
- Contraindications to the axillary block (e.g., local infection)
- 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
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Interventions
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
Locations(1)
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NCT07302997