No Condition, Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block
Conditions
Keywords
axillary block, injection pressure, real-time monitoring
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
Interventions
DEVICESmart 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
Sponsors
Ente Ospedaliero Cantonale, Bellinzona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group | 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
| Measure | Time frame | Description |
|---|---|---|
| Success of the block | Perioperative | Success of the block is defined as no conversion to general anesthesia (avoidance of rescue block, etc.) |
| Number of times of needle tip repositioning | 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 |
| Total number of injection pressure peaks | Perioperative | Total number of injection pressure peaks, i.e. raises of the injection pressure above the threshold of 15 psi, for each injected nerve |
| Quality of anesthesia from a patient's perspective | 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) |
Countries
Switzerland
Contacts
CONTACTRoberto Dossi, MD
Outcome results
None listed