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

Ente Ospedaliero Cantonale, Bellinzona

Status: Enrolling

Conditions: No Condition; Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block

Treatments: Device: Smart Needle Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT07302997

2025-D0048

Details and patient eligibility

About

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

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Smart Needle displaying

Experimental group

Description:

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

Treatment:

Device: Smart Needle Monitoring System

Smart Needle flipped

Other group

Description:

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

Treatment:

Device: Smart Needle Monitoring System