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

NCT07302997 | Recruiting

• 1 other identifier: 2025-D0048
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

axillary block; injection pressure; real-time monitoring

Outcome Measures

Primary Outcomes (1)

• 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

  Perioperative

Secondary Outcomes (4)

• Success of the block

  Perioperative

• Number of times of needle tip repositioning

  Perioperative

• Total number of injection pressure peaks

  Perioperative

• Quality of anesthesia from a patient's perspective

  postoperative, 1 and 7 days after intervention

Study Arms (2)

Smart Needle displaying

EXPERIMENTAL

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. The anesthesiologist will use the real-time visual feedback to maintain a low injection pressure profile (i.e., not higher than 15 psi) and avoid pressure peaks. The anesthesiologist can immediately stop the injection if there is a sudden increase in pressure, reposition the needle and start again, while always maintaining a low injection pressure profile

Device: Smart Needle Monitoring System

Smart Needle flipped

OTHER

The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will be flipped allowing the recording of the injection pressure but not the real-time visualization by the anesthesiologist, who will perform the procedure as usual without a pressure visual feedback

Device: Smart Needle Monitoring System

Interventions

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

Smart Needle displaying; Smart Needle flipped

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Ospedale Regionale di Bellinzona e Valli, EOC

Bellinzona, Switzerland

RECRUITING

Central Study Contacts

Roberto Dossi, MD

CONTACT

+41 (0)91 811 9341; roberto.dossi@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 24, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CH (1)