[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563054":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":62,"collaborators":12,"id":66,"slug":12,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":12,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"No levobupivacaine","NO_INTERVENTION","ESD without local levobupivacaine",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Levobupivacaine","EXPERIMENTAL","levobupivacaine submucosally injected during esopahgeal esd",[18],"Drug: Local levobupivacaine",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Local levobupivacaine","submucosal injection of levobupivacaine during esophageal esad",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Laura S Boer, Degree of medicine","CONTACT","0887550224","l.boer1@antoniusziekenhuis.nl",[32,43,51],{"facility":33,"status":34,"city":35,"state":12,"zip":12,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":12},"UMCG","RECRUITING","Groningen","Netherlands",{"type":38,"coordinates":39},"Point",[40,41],6.56667,53.21917,{"lat":41,"lon":40},{"facility":44,"status":34,"city":45,"state":12,"zip":12,"country":36,"cosmosGeoPoint":46,"geoPoint":50,"contacts":12},"St Antonius Hospital","Nieuwegein",{"type":38,"coordinates":47},[48,49],5.08056,52.02917,{"lat":49,"lon":48},{"facility":52,"status":34,"city":53,"state":12,"zip":12,"country":36,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"UMCU","Utrecht",{"type":38,"coordinates":55},[56,57],5.12222,52.09083,{"lat":57,"lon":56},[60],{"name":61,"role":28,"phone":12,"phoneExt":12,"email":12},"S, Degree of medicine",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Laura Boer","Principle Investigator","100563054",false,"NCT06611176","Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions","Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial","BESD-RCT","Inclusion Criteria:\n\n* Patients age ≥18 years at time of consent\n* Visible lesion in the esophagus, minimum diameter of the lesion ≥20 mm\n* Scheduled for esophageal ESD\n* Informed consent\n\nExclusion Criteria:\n\n* Presence of multiple lesions requiring two or more separate endoscopic resections\n* History of esophageal surgery other than fundoplications\n* History of esophageal ablation therapy\n* History of radiotherapy of the esophagus\n* Esophageal varices\n* Prior endoscopic resection in the same area\n* Uncontrolled coagulopathy\n* Severe medical comorbidities precluding endoscopy\n* Allergy to LB or other amide-type local anaesthesia\n* Current regular use of opioids\n* Other aetiology causing pain similar to post-ESD pain\n* Inability to assess pain due to severe psychiatric or neurological disease\n* Insufficient command of Dutch language\n* Brugada syndrome\n* Incapacitated patients","ALL","18 Years",{"count":76,"type":77},88,"ESTIMATED","INTERVENTIONAL",[80],"NA","Endoscopic submucosal dissection (ESD) is commonly performed for (pre)cancerous lesions in the esophagus. Following ESD, post-procedural chest pain is seen in many patients. Studies have shown that local bupivacaine (BP) into the residual submucosal layer of the resection wound after gastric ESD could reduce post-procedural pain rates effectively. Levobupivacaine (LB) is equipotent to BP regarding analgesic effects, but has a better safety profile. No studies have been performed to evaluate the efficacy of LB after esophageal ESD to reduce pain. Therefore, we want to evaluate the effect on post-procedural pain of local application of LB during esophageal ESD.",[83,14],"Endoscopic Submucosal Dissection",[85,86,87,88],"endoscopic submucosal dissection","ESD","esophagus","analgesic","2024-11-27",{"date":91,"type":92},"2024-12-02","ACTUAL",{"date":94,"type":92},"2024-10-24",{"date":96,"type":77},"2026-03-30",{"name":64,"class":6},3]