Real-time injection-pressure monitoring during ultrasound-guided axillary block
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
NA · Ente Ospedaliero Cantonale, Bellinzona · NCT07302997
This trial tests whether a Smart Needle Monitoring System helps keep injection pressure safely low during ultrasound-guided axillary nerve blocks for adults having surgery below the elbow.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona (other) |
| Locations | 1 site (Bellinzona) |
| Trial ID | NCT07302997 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study uses a Smart Needle Monitoring System during ultrasound-guided axillary peripheral nerve blocks to monitor injection pressure in real time. Clinicians will perform axillary blocks for elective below-elbow surgeries while the device reports pressure to help maintain a low, safe injection force. The study will record device safety, anesthesia quality from the patient perspective, and any neurologic symptoms or signs on postoperative days 1 and 7. Participants are adults (≥18) with ASA I-III status undergoing standard local clinical care at the enrolling hospital.
Who should consider this trial
Good fit: Adults 18 and older scheduled for elective surgery below the elbow who are planned to receive an ultrasound-guided axillary block and can give informed consent are ideal candidates.
Not a fit: Patients with contraindications to axillary block, pre-existing neurologic deficits in the operative limb, BMI ≥35, known local anesthetic allergy, or inability to complete follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could reduce the risk of nerve injury and improve the safety and comfort of axillary blocks by alerting clinicians to high injection pressures.
How similar studies have performed: Prior bench work and smaller clinical reports suggest pressure monitoring can lower the risk of intraneural injection, but robust device-specific clinical evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bellinzona
- Ospedale Regionale di Bellinzona e Valli, EOC — Bellinzona, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Roberto Dossi, MD
- Email: roberto.dossi@eoc.ch
- Phone: +41 (0)91 811 9341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: No Condition, Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block, axillary block, injection pressure, real-time monitoring