Nctid:
NCT06611176
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077554", "term"=>"Levobupivacaine"}], "ancestors"=>[{"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M1832", "name"=>"Levobupivacaine", "asFound"=>"Bacterial", "relevance"=>"HIGH"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>88}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial", "timeFrame"=>"90min", "description"=>"The proportion of patients with major pain within 90 minutes after the procedure comparing the LB and non-LB group. Major pain is defined as a pain score of 4 or higher on a 0-10 Numeric Rating Scale (NRS). The highest pain score reported at any of the three pre-defined time points (30, 60, or 90 minutes after the procedure) will be used to determine if a patient experienced major pain"}], "secondaryOutcomes"=>[{"measure"=>"Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial", "timeFrame"=>"14 days", "description"=>"Pain scores based on a 0-10 NRS within 90 minutes after the procedure, 6 hours after the procedure and thereafter daily up to day 14.\n\n* Cumulative pain throughout 14 days based on the area under the curve of a pain versus time plot.\n* Duration of pain, defined as the number of days until pain scores were reported to be 0 on all following days.\n* Daily and overall use of analgesics up to day 14 post-procedurally registered in a patient diary (electronic or on paper).\n* Length of hospital stay in days\n* Incidence of serious adverse events related to LB administration (including allergic reactions to LB).\n* Incidence of adverse events related to LB ad ministration (including allergic reactions to LB)."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["endoscopic submucosal dissection", "ESD", "esophagus", "analgesic"], "conditions"=>["Endoscopic Submucosal Dissection", "Levobupivacaine"]}, "descriptionModule"=>{"briefSummary"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"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"}, "identificationModule"=>{"nctId"=>"NCT06611176", "acronym"=>"BESD-RCT", "briefTitle"=>"Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions", "organization"=>{"class"=>"OTHER", "fullName"=>"St. Antonius Hospital"}, "officialTitle"=>"Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"2024-510912-66-00"}, "secondaryIdInfos"=>[{"id"=>"2024-510912-66-00", "type"=>"CTIS"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"No levobupivacaine", "description"=>"ESD without local levobupivacaine"}, {"type"=>"EXPERIMENTAL", "label"=>"Levobupivacaine", "description"=>"levobupivacaine submucosally injected during esopahgeal esd", "interventionNames"=>["Drug: Local levobupivacaine"]}], "interventions"=>[{"name"=>"Local levobupivacaine", "type"=>"DRUG", "description"=>"submucosal injection of levobupivacaine during esophageal esad", "armGroupLabels"=>["Levobupivacaine"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Laura S Boer, Degree of medicine", "role"=>"CONTACT", "email"=>"l.boer1@antoniusziekenhuis.nl", "phone"=>"0887550224"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Laura Boer", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Principle Investigator", "investigatorFullName"=>"Laura Boer", "investigatorAffiliation"=>"St. Antonius Hospital"}}}}
