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RECRUITING
NCT07302997
NA

Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block

Sponsor: Ente Ospedaliero Cantonale, Bellinzona

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2025-12-19

Completion Date

2026-12

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DEVICE

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

Locations (1)

Ospedale Regionale di Bellinzona e Valli, EOC

Bellinzona, Switzerland