Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07302997

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Bellinzona e Valli, EOC

Bellinzona, Switzerland

Location status: Recruiting

Location contact

Roberto Dossi, MD

CONTACT

[email protected]

+41 (0)91 811 9341

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart Needle Monitoring System

Device

The 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

Primary outcomes

  1. proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group

    Time frame: Perioperative

    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

Secondary outcomes

  1. Success of the block

    Time frame: Perioperative

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

  2. Number of times of needle tip repositioning

    Time frame: Perioperative

    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

  3. Total number of injection pressure peaks

    Time frame: Perioperative

    Total number of injection pressure peaks, i.e. raises of the injection pressure above the threshold of 15 psi, for each injected nerve

  4. Quality of anesthesia from a patient's perspective

    Time frame: postoperative, 1 and 7 days after intervention

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Dossi, MD

CONTACT

[email protected]

+41 (0)91 811 9341

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

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

Acronym: Smart Needle

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.