Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnte Ospedaliero Cantonale, Bellinzona

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Smart Needle Monitoring System

Treatment groups

34 Participants
are divided into 2 treatment groups