[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563054":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":63,"collaborators":12,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":12,"enrollmentInfo":77,"targetDuration":12,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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",[32,44,52],{"facility":33,"status":34,"city":35,"state":12,"zip":12,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":12},"UMCG","RECRUITING","Groningen","Netherlands","NL",{"type":39,"coordinates":40},"Point",[41,42],6.56667,53.21917,{"lat":42,"lon":41},{"facility":45,"status":34,"city":46,"state":12,"zip":12,"country":36,"countryCode":37,"cosmosGeoPoint":47,"geoPoint":51,"contacts":12},"St Antonius Hospital","Nieuwegein",{"type":39,"coordinates":48},[49,50],5.08056,52.02917,{"lat":50,"lon":49},{"facility":53,"status":34,"city":54,"state":12,"zip":12,"country":36,"countryCode":37,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"UMCU","Utrecht",{"type":39,"coordinates":56},[57,58],5.12222,52.09083,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":12,"phoneExt":12,"email":12},"S, Degree of medicine",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Laura Boer","Principle Investigator","100563054","local-levobupivacaine-for-pain-relief-after-endoscopic-submucosal-dissection-for-esophageal-lesions-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":78,"type":79},88,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85,14],"Endoscopic Submucosal Dissection",[87,88,89,90],"endoscopic submucosal dissection","ESD","esophagus","analgesic","2024-11-27",{"date":93,"type":94},"2024-12-02","ACTUAL",{"date":96,"type":94},"2024-10-24",{"date":98,"type":79},"2026-03-30",{"name":65,"class":6},3]