Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block (NCT07302997) | Clinical Trial Compass
RecruitingNot Applicable
Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block
Switzerland34 participantsStarted 2025-12-19
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group