Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block (Smart Needle)

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

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

Study Overview

• Status: Recruiting
• Conditions: No Condition; Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block
• Intervention / Treatment: Device: Smart Needle Monitoring System

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Dossi, MD; Phone Number: +41 (0)91 811 9341; Email: roberto.dossi@eoc.ch

Study Locations

• Switzerland
  • Bellinzona, Switzerland
    • Recruiting
    • Ospedale Regionale di Bellinzona e Valli, EOC
    • Contact: Roberto Dossi, MD; Phone Number: +41 (0)91 811 9341; Email: roberto.dossi@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Other: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group	The proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group. A peak is defined as an injection pressure reaching a value above the threshold of 15 psi	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the block	Success of the block is defined as no conversion to general anesthesia (avoidance of rescue block, etc.)	Perioperative
Number of times of needle tip repositioning	Number of times of needle tip repositioning, defined as the need to stop the ultrasound- guided PNB procedure to avoid excessive high pressure and reposition the needle tip	Perioperative
Total number of injection pressure peaks	Total number of injection pressure peaks, i.e. raises of the injection pressure above the threshold of 15 psi, for each injected nerve	Perioperative
Quality of anesthesia from a patient's perspective	Interview to the patient with 8 questions about quality of anesthesia from a patient's perspective in terms of pain, perception of needle movements and discomfort during the anesthesia procedure, and overall satisfaction; both Closed-ended questions and questions with scores 0 (worst) to 10 (best)	postoperative, 1 and 7 days after intervention

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: real-time monitoring; axillary block; injection pressure
• Other Study ID Numbers: 2025-D0048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No