{ "FullStudy":{ "Rank":217831, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516268", "OrgStudyIdInfo":{ "OrgStudyId":"886" }, "Organization":{ "OrgFullName":"Tehran University of Medical Sciences", "OrgClass":"OTHER" }, "BriefTitle":"The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery", "OfficialTitle":"the Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane (TAP) Block Under the Guide of Ultrasound to Reduce the Narcotic Dosage, Side Effects and Pain in the First 24 Hours After Cesarean Delivery", "Acronym":"TAP" }, "StatusModule":{ "StatusVerifiedDate":"February 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 19, 2013", "ResultsFirstSubmitQCDate":"February 19, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 27, 2013", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 19, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 27, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Laleh Eslamian", "ResponsiblePartyInvestigatorTitle":"Associated Prof.MD", "ResponsiblePartyInvestigatorAffiliation":"Tehran University of Medical Sciences" }, "LeadSponsor":{ "LeadSponsorName":"Tehran University of Medical Sciences", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Pain" ] }, "KeywordList":{ "Keyword":[ "Cesarean Delivery", "TAP block", "sufentanyl", "Narcotic dosages" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Sufentanyl group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Sufentanyl" ] } },{ "ArmGroupLabel":"Control group", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"In control group we add 1cc salin to 20cc bupivacain in TAP block", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Sufentanyl" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Sufentanyl", "InterventionDescription":"As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.\n\nAs comparator 1cc normal saline is added to bupivacain in control group for Tap block.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Control group", "Sufentanyl group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Narcotic Dosage", "PrimaryOutcomeTimeFrame":"24 h" },{ "PrimaryOutcomeMeasure":"Narcotic Dosage", "PrimaryOutcomeDescription":"The total dosage of morphin consumed by the patients in sufentanil or control group.", "PrimaryOutcomeTimeFrame":"over 24 hours after surgery" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Pain", "SecondaryOutcomeTimeFrame":"24h" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nfemale 18 to 40 Years\nclass ASA 1 and 2\ncandidates for elective cesarean section\n\nExclusion Criteria:\n\nrenal failure\nliver failure\ncardiac disorder\ncoagulopathy\nhepatomegaly\nsplenomegaly\ndrug sensitivity and abuse\nmorbid obesity\nsmoking\nhistory of post operative nausea and vomiting\nmotion sickness\nlocal hypoesthesia", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"40 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Laleh Eslamian, MD", "OverallOfficialAffiliation":"TUMS, Tehran University of Medical Sciences", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Shariati hospital, TUMS", "LocationCity":"Tehran", "LocationZip":"14114", "LocationCountry":"Iran, Islamic Republic of" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Exclusions were based on exclusion criteria previously mentioned.", "FlowRecruitmentDetails":"recruitment period: Jan 2012- Dec 2013 Shariati hospital, a tertiary center", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Sufentanyl Group", "FlowGroupDescription":"IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Control Group", "FlowGroupDescription":"In control group we add 1cc salin to 20cc bupivacain in TAP block" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"25" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"25" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"25" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"25" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"25 & 25", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Sufentanyl Group", "BaselineGroupDescription":"IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Control Group", "BaselineGroupDescription":"In control group we add 1cc salin to 20cc bupivacain in TAP block" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"25" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"25" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"50" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"28.9", "BaselineMeasurementSpread":"3.4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29.9", "BaselineMeasurementSpread":"5.6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"29.1", "BaselineMeasurementSpread":"4.6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Iran, Islamic Republic of", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Narcotic Dosage", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"24 h" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Pain", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"24h" },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Narcotic Dosage", "OutcomeMeasureDescription":"The total dosage of morphin consumed by the patients in sufentanil or control group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mgm,.", "OutcomeMeasureTimeFrame":"over 24 hours after surgery", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Sufentanyl Group", "OutcomeGroupDescription":"IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"In control group we add 1cc salin to 20cc bupivacain in TAP block" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"25" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"25" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"37.2", "OutcomeMeasurementSpread":"16.15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"52.8", "OutcomeMeasurementSpread":"16.7" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"3", "EventsTimeFrame":"24h", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Sufentanyl Group", "EventGroupDescription":"IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"25", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"25" },{ "EventGroupId":"EG001", "EventGroupTitle":"Control Group", "EventGroupDescription":"In control group we add 1cc salin to 20cc bupivacain in TAP block", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"25", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"25" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Nausea and vomiting", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"SNOMED CT", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"25" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"25" } ] } },{ "SeriousEventTerm":"itching", "SeriousEventOrganSystem":"Skin and subcutaneous tissue disorders", "SeriousEventSourceVocabulary":"SNOMED CT", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"25" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"25" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"itching", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventSourceVocabulary":"SNOMED CT", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"25" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"25" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Dr. Laleh Eslamian", "PointOfContactOrganization":"Tehran University of Medical Sciences", "PointOfContactEMail":"leslamian@tums.ac.ir", "PointOfContactPhone":"0098218490", "PointOfContactPhoneExt":"2415" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000017409", "InterventionMeshTerm":"Sufentanil" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000701", "InterventionAncestorTerm":"Analgesics, Opioid" },{ "InterventionAncestorId":"D000009294", "InterventionAncestorTerm":"Narcotics" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000000759", "InterventionAncestorTerm":"Adjuvants, Anesthesia" },{ "InterventionAncestorId":"D000018686", "InterventionAncestorTerm":"Anesthetics, Intravenous" },{ "InterventionAncestorId":"D000018681", "InterventionAncestorTerm":"Anesthetics, General" },{ "InterventionAncestorId":"D000000777", "InterventionAncestorTerm":"Anesthetics" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M18267", "InterventionBrowseLeafName":"Sufentanil", "InterventionBrowseLeafAsFound":"Sufentanil", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2614", "InterventionBrowseLeafName":"Analgesics, Opioid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10828", "InterventionBrowseLeafName":"Narcotics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2688", "InterventionBrowseLeafName":"Anesthetics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19350", "InterventionBrowseLeafName":"Anesthetics, Intravenous", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19345", "InterventionBrowseLeafName":"Anesthetics, General", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AdjAn", "InterventionBrowseBranchName":"Adjuvants, Anesthesia" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }