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Official title Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block
ClinicalTrials.gov ID: NCT07302997
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bellinzona, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bellinzona, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.