{ "FullStudy":{ "Rank":218185, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511627", "OrgStudyIdInfo":{ "OrgStudyId":"RCT GA + SAB for TAH" }, "Organization":{ "OrgFullName":"University of Saskatchewan", "OrgClass":"OTHER" }, "BriefTitle":"Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB", "OfficialTitle":"A Randomized Controlled Trial Comparing Postoperative Pain Following Total Abdominal Hysterectomy With General Anesthetic vs. Combined General and Spinal Anesthetic" }, "StatusModule":{ "StatusVerifiedDate":"November 2016", "OverallStatus":"Withdrawn", "WhyStopped":"Research question was answered by Acta Anaesthesiol Scand 2012; 56: 102-109.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 9, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 10, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 15, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Jacelyn Larson", "ResponsiblePartyInvestigatorTitle":"Faculty", "ResponsiblePartyInvestigatorAffiliation":"University of Saskatchewan" }, "LeadSponsor":{ "LeadSponsorName":"University of Saskatchewan", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The investigators hypothesize that a spinal anesthetic administered prior to the induction of general anesthesia will result in reduced need for pain medication and reduced postoperative pain, as well as reduced hospital stay following a total abdominal hysterectomy." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hysterectomy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"0", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"General Anesthesia", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: General Anesthesia (control group)" ] } },{ "ArmGroupLabel":"General Anesthesia + Spinal Anesthesia", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: General Anesthesia + Spinal anesthesia combined" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"General Anesthesia + Spinal anesthesia combined", "InterventionDescription":"All patients will receive a preoperative multimodal analgesic regime:\n\nTylenol® 975mg per os\nNaproxen® 500 mg per os\n\nPatients will receive a spinal anesthetic with:\n\nBupivacaine 0.5% 10 mg\nFentanyl 10ug\nEpidural Morphine 150ug\n\nAfter the spinal, a general anesthetic will be induced using:\n\nMidazolam 1 - 2 mg intravenously\nFentanyl 1 - 2 ug/kg intravenously\nPropofol 1-3 mg/kg intravenously\nRocuronium 0.3 - 0.9mg/kg intravenously\nfollowed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.\nIntraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg to maintain MAP and heart rate within 20% of baseline.\nPhenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.\nDexamethasone 4mg and Ondansetron 4mg intravenously\nNeostigmine 3mg and Glycopyrrolate 0.6mg intravenously Patients will receive a Morphine PCA to be initiated in the Post Anesthetic Care Unit (PACU).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "General Anesthesia + Spinal Anesthesia" ] } },{ "InterventionType":"Drug", "InterventionName":"General Anesthesia (control group)", "InterventionDescription":"All patients will receive a preoperative multimodal analgesic regime:\n\nTylenol® 975mg per os\nNaproxen® 500 mg per os\n\nGroup I (General anesthetic) patients will receive a general anesthetic :\n\nMidazolam 1 - 2 mg intravenously\nFentanyl 1 - 2 ug/kg intravenously\nPropofol 1-3 mg/kg intravenously\nRocuronium 0.3 - 0.9mg/kg intravenously\nfollowed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.\nIntraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg. to maintain MAP and heart rate within 20% of baseline.\nPhenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.\nDexamethasone 4mg and Ondansetron 4mg intravenously\nNeostigmine 3mg and Glycopyrrolate 0.6mg intravenously\n\nPatients will receive a Morphine PCA as per protocol that will be initiated in the Post Anesthetic Care Unit (PACU).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "General Anesthesia" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Morphine consumption", "PrimaryOutcomeDescription":"The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.", "PrimaryOutcomeTimeFrame":"1 day" },{ "PrimaryOutcomeMeasure":"Total Morphine consumption", "PrimaryOutcomeDescription":"The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.", "PrimaryOutcomeTimeFrame":"Post-operative day 1" },{ "PrimaryOutcomeMeasure":"Total Morphine consumption", "PrimaryOutcomeDescription":"The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.", "PrimaryOutcomeTimeFrame":"Post-operative day 2" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"In the PACU: within the first 5 minutes" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"In the PACU: after 30 minutes" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"In the PACU: after 60 minutes." },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"Upon arrival on the post-operative ward" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On the post-operative ward: after 1 hour" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On the post-operative ward: after 4 hours" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative day 1 at 02:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative days 1 at 06:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative days 1 at 10:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative days 1 at 14:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative days 1 at 18:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative days 1 at 22:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative day 2 at 02:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative day 2 at 06:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative day 2 at 10:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative day 2 at 14:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative day 2 at 18:00" },{ "SecondaryOutcomeMeasure":"Pain score on the VAS", "SecondaryOutcomeTimeFrame":"On post-operative day 2 at 22:00" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAmerican Society of Anesthesiologists' (ASA) I and II patients undergoing elective Total Abdominal Hysterectomy at the Saskatoon City Hospital\nLower transverse abdominal incision\n\nExclusion Criteria:\n\nBMI > 40\nThe TAH is treatment for cancer\nA history of regular opioid use\nAny medical condition that would make a spinal inadvisable,\nAn allergy or medical condition that would make it inadvisable to receive the drugs used in this study (eg. Peptic ulcer disease), or\nIf you will also be having a salpingo-oophorectomy).", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jacelyn Larson, MD, FRCPC", "OverallOfficialAffiliation":"University of Saskatchewan", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Saskatoon City Hospital", "LocationCity":"Saskatoon", "LocationState":"Saskatchewan", "LocationZip":"S7K0M7", "LocationCountry":"Canada" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000000777", "InterventionMeshTerm":"Anesthetics" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M2688", "InterventionBrowseLeafName":"Anesthetics", "InterventionBrowseLeafAsFound":"Anesthesia", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000010149", "ConditionMeshTerm":"Pain, Postoperative" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000011183", "ConditionAncestorTerm":"Postoperative Complications" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000010146", "ConditionAncestorTerm":"Pain" },{ "ConditionAncestorId":"D000009461", "ConditionAncestorTerm":"Neurologic Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11652", "ConditionBrowseLeafName":"Pain, Postoperative", "ConditionBrowseLeafAsFound":"Postoperative Pain", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12648", "ConditionBrowseLeafName":"Postoperative Complications", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10987", "ConditionBrowseLeafName":"Neurologic Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" } ] } } } } } }