Real-time monitoring of local anesthetic injection pressure during peripheral loco-regional anesthesia

Zusammenfassung der Studie

Several studies have shown that an increase in local anesthetic injection pressure may indicate incorrect positioning of the needle tip, within a nerve or a vessel, or accidental contact between the needle and nerve. The use of a medical device that allows continuous and real-time monitoring of injection pressure during loco-regional anesthesia could help achieve a more effective and safer injection. In this trial, we examine whether the new medical device Smart Needle Monitoring System is effective and safe. The Smart Needle Monitoring System consists of a standard needle, used in clinical practice for performing loco-regional anesthesia, within which a sensor is incorporated that measures the injection pressure at the needle tip. The needle is connected to a screen that allows visualization and recording of the local anesthetic injection pressure. In the event of a sudden increase in injection pressure, the anesthetist can immediately stop the injection, reposition the needle, and restart. In this trial, patients undergoing surgery below the elbow (of the hand, forearm, etc.) under ultrasound-guided peripheral loco-regional anesthesia via the axilla are randomly divided into 2 groups. In both groups, the standard needle of the Smart Needle Monitoring System is used to inject the anesthetic. Each group undergoes a different intervention: in the experimental group, the anesthetist visualizes and controls the injection pressure in real-time on the screen connected to the needle, while in the control group, the anesthetist injects the anesthetic without visualizing and controlling the injection pressure in real-time, as is done in standard clinical practice. Participation involves 3 visits (1 hospital visit for the surgical procedure plus 2 phone interviews for post-operative evaluation) and lasts for 8 days.

(BASEC)

Untersuchte Intervention

In the experimental group, the Smart Needle Monitoring System medical device is used to perform ultrasound-guided axillary loco-regional anesthesia. The anesthetist uses the standard needle of the Smart Needle Monitoring System to inject the local anesthetic. The screen connected to the needle displays in real-time and records the injection pressure profile during anesthesia. The anesthetist will use real-time visual feedback to maintain low injection pressure and avoid pressure spikes.

In the control group, the Smart Needle Monitoring System medical device is used to perform ultrasound-guided axillary loco-regional anesthesia. The anesthetist uses the standard needle of the Smart Needle Monitoring System to inject the local anesthetic. Unlike the experimental group, the screen connected to the needle will be rotated, allowing for the recording of injection pressure but not real-time visualization by the anesthetist, who will perform the procedure as usual in standard clinical practice without visual feedback of the injection pressure.

(BASEC)

Untersuchte Krankheit(en)

Surgery below the elbow (e.g., hand surgery, forearm surgery, etc.) under ultrasound-guided peripheral loco-regional anesthesia via the axilla

(BASEC)

Sponsor

Servizio di Anestesiologia, Ospedale Regionale di Bellinzona e Valli EOC, sede San Giovanni.

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Tessin

(BASEC)

Datum der Bewilligung durch die Ethikkommission

02.06.2025

(BASEC)

Ergebnisse der Studie