NCT07302997

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Ente Ospedaliero Cantonale, Bellinzona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• No Condition
• Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-19
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-24
• Last updated: 2026-03-13

Locations

1 site across 1 country: Switzerland