[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616237":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":24,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":24,"enrollmentInfo":60,"targetDuration":24,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Ente Ospedaliero Cantonale, Bellinzona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Smart Needle displaying","EXPERIMENTAL","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.\n\nThe anesthesiologist will use the real-time visual feedback to maintain a low injection pressure profile (i.e., not higher than 15 psi) and avoid pressure peaks. The anesthesiologist can immediately stop the injection if there is a sudden increase in pressure, reposition the needle and start again, while always maintaining a low injection pressure profile",[13],"Device: Smart Needle Monitoring System",{"label":15,"type":6,"description":16,"interventionNames":17},"Smart Needle flipped","The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will be flipped allowing the recording of the injection pressure but not the real-time visualization by the anesthesiologist, who will perform the procedure as usual without a pressure visual feedback",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Roberto Dossi, MD","CONTACT","+41 (0)91 811 9341","roberto.dossi@eoc.ch",[32],{"facility":33,"status":34,"city":35,"state":24,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ospedale Regionale di Bellinzona e Valli, EOC","RECRUITING","Bellinzona","Switzerland","CH",{"type":39,"coordinates":40},"Point",[41,42],9.01703,46.19278,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Dossi Roberto","MD","100616237","real-time-monitoring-of-the-injection-pressure-during-the-peripheral-nerve-block-100616237",false,"NCT07302997","Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve 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","Smart Needle","Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* Age ≥ 18 years\n* Scheduled for elective surgery below the elbow (e.g., hand surgery, distal radius surgery, forearm surgery) requiring an axillary block\n* ASA physical status I-III\n* Ability to understand the investigation\n* Ability and willingness to follow and complete the procedures of the investigation\n\nExclusion Criteria:\n\n* Contraindications to the axillary block (e.g., local infection)\n* Refusal of locoregional anesthesia for the surgical procedure\n* Pre-existing neurologic deficits in the operative extremity\n* Body Mass Index ≥ 35 kg\u002Fm2\n* Known allergy to local anesthetic (mepicavaine hydrochloride)\n* Inability to comply with post-operative evaluations e.g. due to language problems, psychological disorders, dementia, etc. of the subject","ALL","18 Years",{"count":61,"type":62},34,"ESTIMATED","INTERVENTIONAL",[65],"NA","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.\n\nParticipants will:\n\n* be operated locally according to standard clinical practice\n* undergo post-anesthesia recovery and any neurologic symptoms or signs assessment on postoperative days 1 and 7",[68,69],"No Condition","Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block",[71,72,73],"axillary block","injection pressure","real-time monitoring","2026-03-12",{"date":76,"type":77},"2026-03-13","ACTUAL",{"date":79,"type":77},"2025-12-19",{"date":81,"type":62},"2026-12",{"name":5,"class":6},1]