[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551143":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":26,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"St. Paul's Hospital, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Injection","EXPERIMENTAL","\\- Injection 0.25% bupivacaine with 1:200,000 epinephrine",[13],"Drug: Sensorcaine with Epinephrine",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham injection","PLACEBO_COMPARATOR","\\- Sham injection (only puncture, no injecting anything)",[19],"Other: Sham injection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sensorcaine with Epinephrine","The combination contains 0.25% bupivacaine hydrochloride (2.5 mg\u002FmL) and epinephrine bitartrate \\[(1:200,000) 5 mcg\u002FmL\\] per vial.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Punctures without any medication injected onto the septum",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Amin Javer","CONTACT","6048069926","sinusdoc@me.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":26},"St.Paul's Hospital Sinus Center","RECRUITING","Vancouver","British Columbia","V6Z 1Y6","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-123.11934,49.24966,{"lat":49,"lon":48},{"type":52,"investigatorFullName":32,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Clinical Professor","100551143","phase-2-bupivacaine-and-epinephrine-injection-study-100551143",false,"NCT06456255","Bupivacaine and Epinephrine Injection Study","Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 19 years or older\n* Scheduled for primary ESS (including septoplasty)\n\nExclusion Criteria:\n\n* Cystic fibrosis\n* Systemic vasculitis or any bleeding disorders\n* Known or suspected hypersensitivity to bupivacaine or epinephrine\n* Previous sinus surgery\n* Inhaled drug use (i.e., cocaine) in the preceding 6 months\n* Nasal tumors\n* Patients on antiarrhythmics.\n* Patients with history of severe liver illness.\n* Patients identified as high-risk for complications during preoperative assessment with the anesthesiologist (e.g. untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism and diabetes)","ALL","19 Years",{"count":64,"type":65},80,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE2","PHASE3","Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.",[72,73,74],"Sinus Disease","Anesthesia","Bleeding",[76,77,78],"endoscopic sinus surgery","bupivacaine","epinephrine","2025-05-12",{"date":81,"type":82},"2025-05-15","ACTUAL",{"date":84,"type":82},"2024-11-15",{"date":86,"type":65},"2025-07",{"name":32,"class":6},1]