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

Ente Ospedaliero Cantonale, Bellinzona34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Perioperative

Secondary Outcomes

Success of the block

Success of the block is defined as no conversion to general anesthesia (avoidance of rescue block, etc.)

Time frame: Perioperative

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

Time frame: Perioperative

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

Time frame: Perioperative

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)

Time frame: postoperative, 1 and 7 days after intervention

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts