Nctid:
NCT06616220
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012600", "term"=>"Scoliosis"}], "ancestors"=>[{"id"=>"D000013121", "term"=>"Spinal Curvatures"}, {"id"=>"D000013122", "term"=>"Spinal Diseases"}, {"id"=>"D000001847", "term"=>"Bone Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}], "browseLeaves"=>[{"id"=>"M15417", "name"=>"Scoliosis", "asFound"=>"Scoliosis", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M15918", "name"=>"Spinal Curvatures", "relevance"=>"LOW"}, {"id"=>"M15919", "name"=>"Spinal Diseases", "relevance"=>"LOW"}, {"id"=>"M5126", "name"=>"Bone Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000003907", "term"=>"Dexamethasone"}, {"id"=>"D000077212", "term"=>"Ropivacaine"}], "ancestors"=>[{"id"=>"D000000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000000932", "term"=>"Antiemetics"}, {"id"=>"D000001337", "term"=>"Autonomic Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D000005938", "term"=>"Glucocorticoids"}, {"id"=>"D000006728", "term"=>"Hormones"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}], "browseLeaves"=>[{"id"=>"M7102", "name"=>"Dexamethasone", "asFound"=>"High", "relevance"=>"HIGH"}, {"id"=>"M235549", "name"=>"Dexamethasone acetate", "relevance"=>"LOW"}, {"id"=>"M1700", "name"=>"Ropivacaine", "asFound"=>"Stress", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-01-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"First need of opioid analgesia", "timeFrame"=>"48 hours after surgery", "description"=>"Time after surgery when the patient needs opiate for the first time"}], "secondaryOutcomes"=>[{"measure"=>"Opioid consumption", "timeFrame"=>"48 hours after procedure", "description"=>"Total opiate consumption after surgery"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"4 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"8 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"12 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"24 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"48 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"Nerve damage [range 0-4]", "timeFrame"=>"12 hours after surgery", "description"=>"Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)"}, {"measure"=>"Nerve damage [range 0-4]", "timeFrame"=>"24 hours after surgery", "description"=>"Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)"}, {"measure"=>"Nerve damage [range 0-4]", "timeFrame"=>"48 hours after surgery", "description"=>"Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)"}, {"measure"=>"glucose", "timeFrame"=>"12 hours after surgery", "description"=>"blood glucose level"}, {"measure"=>"glucose", "timeFrame"=>"24 hours after surgery", "description"=>"blood glucose level"}, {"measure"=>"glucose", "timeFrame"=>"48 hours after surgery", "description"=>"blood glucose level"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Scoliosis", "Scoliosis Idiopathic", "Scoliosis; Adolescence"]}, "descriptionModule"=>{"briefSummary"=>"Effect of perineurial dexamethasone on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.", "detailedDescription"=>"This study proposes to explore the effect of perineurial Dexamethasone on erector spinal plane block duration for pediatric idiopathic scoliosis surgery.\n\nChildren need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.\n\nThe safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "minimumAge"=>"10 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* children scheduled for idiopathic scoliosis surgery\n* age \\>10 and \\<18 years\n\nExclusion Criteria:\n\n* age \\< 10 years\n* age \\< 18 years\n* infection at the site of the regional blockade\n* coagulation disorders\n* immunodeficiency\n* ASA= or \\>4\n* steroid medication in regular use"}, "identificationModule"=>{"nctId"=>"NCT06616220", "briefTitle"=>"Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Poznan University of Medical Sciences"}, "officialTitle"=>"Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic", "orgStudyIdInfo"=>{"id"=>"11/2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"DEXAMETHASONE", "description"=>"0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block", "interventionNames"=>["Drug: Dexamethasone"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"CONTROL", "description"=>"0.2% ropivacaine for erector spinae plane block", "interventionNames"=>["Drug: 0.9%NaCl"]}], "interventions"=>[{"name"=>"Dexamethasone", "type"=>"DRUG", "otherNames"=>["Dexaethasone"], "description"=>"administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block", "armGroupLabels"=>["DEXAMETHASONE"]}, {"name"=>"0.9%NaCl", "type"=>"DRUG", "otherNames"=>["administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block"], "description"=>"0.9% NaCl", "armGroupLabels"=>["CONTROL"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"61-545", "city"=>"Poznań", "state"=>"Wielkopolska", "country"=>"Poland", "facility"=>"Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland", "geoPoint"=>{"lat"=>52.40692, "lon"=>16.92993}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Poznan University of Medical Sciences", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
