Nctid:
NCT06225323
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011537", "term"=>"Pruritus"}], "ancestors"=>[{"id"=>"D000012871", "term"=>"Skin Diseases"}, {"id"=>"D000012877", "term"=>"Skin Manifestations"}], "browseLeaves"=>[{"id"=>"M14396", "name"=>"Pruritus", "asFound"=>"Pruritus", "relevance"=>"HIGH"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M15680", "name"=>"Skin Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008012", "term"=>"Lidocaine"}], "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"}, {"id"=>"D000000889", "term"=>"Anti-Arrhythmia Agents"}, {"id"=>"D000061567", "term"=>"Voltage-Gated Sodium Channel Blockers"}, {"id"=>"D000026941", "term"=>"Sodium Channel Blockers"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M11014", "name"=>"Lidocaine", "asFound"=>"Self-", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}, {"id"=>"M4213", "name"=>"Anti-Arrhythmia Agents", "relevance"=>"LOW"}, {"id"=>"M23177", "name"=>"Sodium Channel Blockers", "relevance"=>"LOW"}, {"id"=>"M30025", "name"=>"Diuretics, Potassium Sparing", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Arrhythmia Agents", "abbrev"=>"AnArAg"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>136}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2024-04-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-07-30", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The incidence of pruritis", "timeFrame"=>"24 hours postoperatively", "description"=>"The incidence of pruritis will be classifies as moderate (affecting a larger area, such as face and arms or face and anterior surface of thorax, but not disturbing the patient, and therefore not requiring treatment) , severe (extensive or generalized, often disturbing the patient and may need treatment)or very sever(disturbing the patient and treatment was indicated)."}], "secondaryOutcomes"=>[{"measure"=>"The severity of pruritis", "timeFrame"=>"24 hours postoperatively", "description"=>"The severity of pruritis will be assessed using qualitative scales (Pruritus Severity Scale)such as none, mild, moderate, severe or very sever pruritus."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Lidocaine Infusion", "Neuraxial Opioid", "Pruritus", "Cesarean Section"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this study is to assess the efficacy and potency of lidocaine infusion as a preventive measure on pruritus response after injection of 200 micro gram morphine with bupivacaine subarachnoid block, spinal anesthesia, in cesarean section.", "detailedDescription"=>"Neuraxial opioids (NO) are one of the most widely used methods for postpartum analgesia, for cesarean section analgesia, and many other surgical procedures.\n\nThe pruritus induced by NO is an unpleasant, subjective, and irritating sensation that causes scratching response.\n\nPruritus begins shortly after anesthesia, with the onset depending on the type, route and dosage of opioid used. Pruritus invoked by lipid-soluble opioids such as fentanyl and sufentanil is of shorter duration, and the use of the minimum or small dose from opioids in addition of local anesthetics seems to decrease the prevalence and the severity of itching. Pruritus invoked by intrathecal morphine is of longer duration and is difficult to treat. Intrathecal administration, of opioids reach peak concentrations in the cerebrospinal fluid almost immediately. \\]. But, after epidural administration, there is a delay in the rise to peak concentration (10-20 min with fentanyl and 1-4 h with morphine)."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"40 years", "minimumAge"=>"20 years", "genderBased"=>true, "genderDescription"=>"Women undergoing Cesarean section", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age from 20 to 40 years.\n* Weight from 50 to 90 kg.\n* Women undergoing Cesarean section.\n\nExclusion Criteria:\n\n* Patient with known allergies to lidocaine.\n* Preexisting pruritus.\n* Coexisting skin disorders.\n* Contraindications to spinal anesthesia.\n* Preeclampsia.\n* Eclampsia.\n* Major systemic diseases.\n* Refusal to participate.\n* Uses of any current drugs have potential effects on post-operative itching as steroidal ,nonsteroidal ,ondanstern, propofol, midazolam during study period."}, "identificationModule"=>{"nctId"=>"NCT06225323", "briefTitle"=>"Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section", "organization"=>{"class"=>"OTHER", "fullName"=>"Aswan University"}, "officialTitle"=>"Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section Double-blinded, Randomized Control Clinical Trial", "orgStudyIdInfo"=>{"id"=>"Aswu/668/10/22"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Lidocaine group", "description"=>"Patients will receive Lidocaine infusion for 6 hours", "interventionNames"=>["Drug: Lidocaine"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Control group", "description"=>"Patients will receive normal saline infusion for 6 hours", "interventionNames"=>["Other: Saline"]}], "interventions"=>[{"name"=>"Lidocaine", "type"=>"DRUG", "description"=>"Patients will receive Lidocaine infusion for 6 hours. After cord clamping and according to ideal body calculate the bolus dose 1.5 mg/kg of lidocaine 1% and complete the dose by normal saline to 20 ml total volume will be given in 10 min.\n\nThe infusion dose 1.5 mg/kg/hour of lidocaine 1% for 6 hours in automated syringe pump (aquavesar fixed variable rate 100ml volume) 100 ml then follow up without infusion up to 24 hours.", "armGroupLabels"=>["Lidocaine group"]}, {"name"=>"Saline", "type"=>"OTHER", "description"=>"Patients will receive normal saline infusion for 6 hours. After cord clamping 20 ml total volume normal saline will be given in 10 min.\n\nThe infusion dose 1.5 mg/kg/hour of normal saline for 6 hours in automated syringe pump (aquavesar fixed variable rate 100ml volume) 100 ml then follow up without infusion up to 24 hours.", "armGroupLabels"=>["Control group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"81511", "city"=>"Aswan", "country"=>"Egypt", "facility"=>"Aswan University", "geoPoint"=>{"lat"=>24.09082, "lon"=>32.89942}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"After the end of study for one year.", "ipdSharing"=>"YES", "description"=>"The data will be available upon a reasonable request from the corresponding author after the end of study for one year.", "accessCriteria"=>"The data will be available upon a reasonable request from the corresponding author."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Aswan University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine", "investigatorFullName"=>"Ayman Mohamady Eldemrdash", "investigatorAffiliation"=>"Aswan University"}}}}
