Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smart Needle Monitoring System.
- Who it may be relevant to
- Registry conditions: No Condition, Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
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
Interventions
- Device Smart Needle Monitoring System
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 outcome measures
- proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group [Time frame: Perioperative]
Secondary outcome measures (4)
- Success of the block [Time frame: Perioperative]
- Number of times of needle tip repositioning [Time frame: Perioperative]
- Total number of injection pressure peaks [Time frame: Perioperative]
- Quality of anesthesia from a patient's perspective [Time frame: postoperative, 1 and 7 days after intervention]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Switzerland · 1 center
- Ospedale Regionale di Bellinzona e Valli, EOC — Bellinzona
Identifiers
NCT: NCT07302997 · 2025-D0048