{ "FullStudy":{ "Rank":218036, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513564", "OrgStudyIdInfo":{ "OrgStudyId":"ON-07-008-RAS" }, "Organization":{ "OrgFullName":"Northern Orthopaedic Division, Denmark", "OrgClass":"OTHER" }, "BriefTitle":"Multimodal Perioperative Pain Management", "OfficialTitle":"Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery" }, "StatusModule":{ "StatusVerifiedDate":"May 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2001" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2003", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2006", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 13, 2011", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 27, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 28, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Northern Orthopaedic Division, Denmark", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Vejle Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Aarhus University Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Copenhagen University Hospital, Denmark", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery.\n\nThe objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.", "DetailedDescription":"Major spine surgery is usually associated with high postoperative pain scores and opioid requirements. Epidural analgesia has been reported to be an effective and safe method to control postoperative pain after spinal instrumentation surgery, but the overall effects of pain management on postoperative length of stay and recovery remains debatable.\n\nHowever, in a multimodal approach, including multimodal non-opioid analgesia to control postoperative pathophysiology and rehabilitation, complications and hospital stay have been reduced after arthroscopy, hip arthroplasty and knee arthroplasty, hip fractures and abdominal surgery and other procedures, when combined with an enhanced recovery program.\n\nThe aim of the study is to assess the effect and safety of a combined analgesic regimen consisting of local anesthetic, intra-operative and post-operative continuous epidural analgesia and a single dose ketorolac together with a fast track rehabilitation program after 360 degree lumbar fusion for degenerative disc disease and spondylolisthesis < 2" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Degenerative Spondylolisthesis" ] }, "KeywordList":{ "Keyword":[ "Disc disease", "Spondylolisthesis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"120", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Conservative treatment program", "ArmGroupType":"Experimental", "ArmGroupDescription":"The control group were supervised isometric passive and active exercises by a physiotherapist. On the second day patients were allowed to sit in a chair being instructed to a low intensity exercise training program with regard to back pain and fear of activity. From the third or fourth day stair training, low intensity exercise, daily walks and instruction in home training were allowed.\n\nThe intervention group received the same training program but with a faster program plus a higher intensity exercise-training program.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Postoperative epidural morphine", "Drug: Local anaesthesia" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Postoperative epidural morphine", "InterventionDescription":"The control group received postoperative epidural morphine 0.4 mg/ml four times a day, epidural bupivacaine 2.5 mg/ml, 3-4 ml on request for 75 hours and a 7 day rehabilitation program.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Conservative treatment program" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Convalescence after lumbar fusion" ] } },{ "InterventionType":"Drug", "InterventionName":"Local anaesthesia", "InterventionDescription":"Preemptively and posteruptively, the intervention group received local anaesthesia with bupivacaine 2.5 mg/ml, 10 + 10 ml posteriorly and 10 + 10 anteriorly; preemptive epidural analgesia with 3 ml lidocaine 20 mg/ml, 3 ml, 10 ml morphine 0.4 mg/ml plus 5 ml bupivacaine; postoperative continuous epidural analgesia for 72 hours with 250 ml with bupivacaine 1 mg/ml + morphine 50 ug/ml, and 0.5 ml epinephrine 1 mg/ml, 4 ml/hour, and after wound closure ketorolac 30 mg intravenously.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Conservative treatment program" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Convalescence after lumbar fusion." ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Multimodal management of lumbar fusion", "PrimaryOutcomeDescription":"Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index", "PrimaryOutcomeTimeFrame":"Two years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Multimodal management of lumbar fusion", "SecondaryOutcomeDescription":"Assessment of the effects of at fast track program with ongoing epidural analgesia, multimodal pain treatment including ketorolac and early intensive mobilization and physiotherapy.", "SecondaryOutcomeTimeFrame":"Two years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDegenerative disc disease and Spondylolisthesis up to grade 2 at one to the three lower lumbar levels.\n\nExclusion Criteria:\n\nPrevious fusion, metabolic bone disease, severe comorbidity or psychological instability.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Sten Rasmussen, M.D.", "OverallOfficialAffiliation":"Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"David S. Krum-Moeller, M.D.", "OverallOfficialAffiliation":"Department of Orthopaedic Surgery, Vejle and Give Hospital", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Lene R. Lauridsen", "OverallOfficialAffiliation":"Department of Orthopaedic Surgery, Vejle and Give Hospital", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Henrik Kehlet, M.D.", "OverallOfficialAffiliation":"Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Orthopaedic Research Unit, Aarhus University, Aalborg Hospital", "LocationCity":"Aalborg", "LocationZip":"9000", "LocationCountry":"Denmark" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000009020", "InterventionMeshTerm":"Morphine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000701", "InterventionAncestorTerm":"Analgesics, Opioid" },{ "InterventionAncestorId":"D000009294", "InterventionAncestorTerm":"Narcotics" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M2688", "InterventionBrowseLeafName":"Anesthetics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10565", "InterventionBrowseLeafName":"Morphine", "InterventionBrowseLeafAsFound":"Morphine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2614", "InterventionBrowseLeafName":"Analgesics, Opioid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10828", "InterventionBrowseLeafName":"Narcotics", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013168", "ConditionMeshTerm":"Spondylolisthesis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000013169", "ConditionAncestorTerm":"Spondylolysis" },{ "ConditionAncestorId":"D000055009", "ConditionAncestorTerm":"Spondylosis" },{ "ConditionAncestorId":"D000013122", "ConditionAncestorTerm":"Spinal Diseases" },{ "ConditionAncestorId":"D000001847", "ConditionAncestorTerm":"Bone Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14546", "ConditionBrowseLeafName":"Spondylolisthesis", "ConditionBrowseLeafAsFound":"Spondylolisthesis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14547", "ConditionBrowseLeafName":"Spondylolysis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M26580", "ConditionBrowseLeafName":"Spondylosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14502", "ConditionBrowseLeafName":"Spinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3708", "ConditionBrowseLeafName":"Bone Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" } ] } } } } } }