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

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

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