RecruitingNot ApplicableNCT07302997

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


Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Enrollment

34 participants

Start Date

Dec 19, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Smart Needle Monitoring System for people with no condition and real-time monitoring of the injection pressure during ultrasound-guided axillary block. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmart 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


Locations(1)

Ospedale Regionale di Bellinzona e Valli, EOC

Bellinzona, Switzerland

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NCT07302997


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