Nctid:
NCT06233617
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000013130", "term"=>"Spinal Stenosis"}, {"id"=>"D000013122", "term"=>"Spinal Diseases"}], "ancestors"=>[{"id"=>"D000001847", "term"=>"Bone Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}], "browseLeaves"=>[{"id"=>"M15927", "name"=>"Spinal Stenosis", "asFound"=>"Spinal Stenosis", "relevance"=>"HIGH"}, {"id"=>"M6475", "name"=>"Constriction, Pathologic", "relevance"=>"LOW"}, {"id"=>"M15919", "name"=>"Spinal Diseases", "asFound"=>"Spine Disease", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "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"=>"C000018038", "term"=>"Dexamethasone acetate"}, {"id"=>"D000020927", "term"=>"Dexmedetomidine"}, {"id"=>"D000077212", "term"=>"Ropivacaine"}, {"id"=>"C000101468", "term"=>"BB 1101"}], "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"=>"D000011480", "term"=>"Protease Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000006993", "term"=>"Hypnotics and Sedatives"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000058647", "term"=>"Adrenergic alpha-2 Receptor Agonists"}, {"id"=>"D000000316", "term"=>"Adrenergic alpha-Agonists"}, {"id"=>"D000000322", "term"=>"Adrenergic Agonists"}, {"id"=>"D000018663", "term"=>"Adrenergic Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000000777", "term"=>"Anesthetics"}], "browseLeaves"=>[{"id"=>"M7102", "name"=>"Dexamethasone", "asFound"=>"High", "relevance"=>"HIGH"}, {"id"=>"M235549", "name"=>"Dexamethasone acetate", "asFound"=>"High", "relevance"=>"HIGH"}, {"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M22662", "name"=>"Dexmedetomidine", "asFound"=>"Human", "relevance"=>"HIGH"}, {"id"=>"M1700", "name"=>"Ropivacaine", "asFound"=>"Stress", "relevance"=>"HIGH"}, {"id"=>"M199152", "name"=>"BB 1101", "asFound"=>"High", "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"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M10043", "name"=>"Hypnotics and Sedatives", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20746", "name"=>"Adrenergic Agents", "relevance"=>"LOW"}, {"id"=>"M3668", "name"=>"Adrenergic alpha-Agonists", "relevance"=>"LOW"}, {"id"=>"M3673", "name"=>"Adrenergic Agonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "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"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>90}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2025-04-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-26", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"first need of opiate", "timeFrame"=>"48 hours", "description"=>"Time after surgery when the patient needs opiate for the first time"}], "secondaryOutcomes"=>[{"measure"=>"Opioid consumption", "timeFrame"=>"48 hours", "description"=>"Total opiate consumption after surgery"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"Time Frame: 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"=>"Time Frame: 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"=>"Time Frame: 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"=>"Time Frame: 16 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"Time Frame: 20 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"Time Frame: 24 hours after surgery", "description"=>"NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)"}, {"measure"=>"NLR", "timeFrame"=>"48 hours after surgery", "description"=>"Neutrophil-to-lymphocyte ratio"}, {"measure"=>"PLR", "timeFrame"=>"48 hours after surgery", "description"=>"Platelet-to-lymphocyte ratio"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Spinal Fusion", "Spine Disease", "Spinal Stenosis", "Erector Spinae Plane Block"]}, "descriptionModule"=>{"briefSummary"=>"Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.", "detailedDescription"=>"This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.\n\nAfter spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.\n\nThe safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.\n\nThere is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block.\n\nIn this study, investigators compare perineural Dexamethasone and Dexmedetomidine.\n\nThe investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region,\n* aged \\>18 years and \\<100 years\n* ASA physical status 1, 2 or 3.\n\nExclusion Criteria:\n\n* refuse to participate,\n* history of opioid abuse,\n* infection of the puncture site,\n* aged \\<18 years and \\>100 years\n* ASA 4 and 5"}, "identificationModule"=>{"nctId"=>"NCT06233617", "briefTitle"=>"Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Poznan University of Medical Sciences"}, "officialTitle"=>"Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery", "orgStudyIdInfo"=>{"id"=>"3/2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"placebo", "description"=>"0.2% ropivacaine for erector spinae plane block", "interventionNames"=>["Drug: 0.9% Sodium Chloride Injection"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Dexamethasone", "description"=>"0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block", "interventionNames"=>["Drug: Dexamethasone 4 Mg/mL Injectable Solution"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Dexmedetomidine", "description"=>"0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block", "interventionNames"=>["Drug: Dexmedetomidine injection"]}], "interventions"=>[{"name"=>"0.9% Sodium Chloride Injection", "type"=>"DRUG", "otherNames"=>["0.9% Sodium Chloride iv."], "description"=>"biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block", "armGroupLabels"=>["placebo"]}, {"name"=>"Dexamethasone 4 Mg/mL Injectable Solution", "type"=>"DRUG", "otherNames"=>["0,2% ropivacaine with 4mg Dexamethasone iv"], "description"=>"biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block", "armGroupLabels"=>["Dexamethasone"]}, {"name"=>"Dexmedetomidine injection", "type"=>"DRUG", "otherNames"=>["0,2% ropivacaine with 50ug Dexmedetomidine"], "description"=>"biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block", "armGroupLabels"=>["Dexmedetomidine"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"61-701", "city"=>"Poznan", "state"=>"Poznań", "status"=>"RECRUITING", "country"=>"Poland", "contacts"=>[{"name"=>"Malgorzata Domagalska, Ph.D.", "role"=>"CONTACT", "email"=>"m.domagalska@icloud.com", "phone"=>"608762068"}], "facility"=>"Poznan University of Medical Sciences", "geoPoint"=>{"lat"=>52.40692, "lon"=>16.92993}}], "centralContacts"=>[{"name"=>"Malgorzata Domagalska, PhD", "role"=>"CONTACT", "email"=>"m.domagalska@icloud.com", "phone"=>"+48 61 873 83 03"}, {"name"=>"Malgorzata Domagalska, PhD", "role"=>"CONTACT", "email"=>"m.domagalska@icloud.com", "phone"=>"608762068"}], "overallOfficials"=>[{"name"=>"Malgorzata Domagalska, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Poznań University of Medical Sciences"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Poznan University of Medical Sciences", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
