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
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
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
Parallel
Smart Needle Monitoring System
DeviceThe 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
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
Success of the block
Success of the block is defined as no conversion to general anesthesia (avoidance of rescue block, etc.)
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
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
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)
Click on the lead sponsor to view all of their trials.
