Nctid:
NCT06233630
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010003", "term"=>"Osteoarthritis"}, {"id"=>"D000020370", "term"=>"Osteoarthritis, Knee"}], "ancestors"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M22168", "name"=>"Osteoarthritis, Knee", "asFound"=>"Knee Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000077212", "term"=>"Ropivacaine"}, {"id"=>"D000019999", "term"=>"Pharmaceutical Solutions"}], "ancestors"=>[{"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "asFound"=>"Based", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "asFound"=>"Acid", "relevance"=>"HIGH"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}, {"id"=>"M1700", "name"=>"Ropivacaine", "asFound"=>"Stress", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>90}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-03-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-08-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-16", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Opioid consumption", "timeFrame"=>"48 hours", "description"=>"Total opiate consumption after surgery"}], "secondaryOutcomes"=>[{"measure"=>"first need of opiate", "timeFrame"=>"48 hours", "description"=>"Time after surgery when the patient needs opiate for the first time"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"4 hours after surgery", "description"=>"Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"8 hours after surgery", "description"=>"Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"12 hours after surgery", "description"=>"Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"16 hours after surgery", "description"=>"Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"20 hours after surgery", "description"=>"Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)"}, {"measure"=>"Numerical Rating Scale [range 0:10]", "timeFrame"=>"24 hours after surgery", "description"=>"Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)"}, {"measure"=>"NLR", "timeFrame"=>"24 hours postoperatively", "description"=>"Neutrophil-to-lymphocyte ratio"}, {"measure"=>"PLR", "timeFrame"=>"24 hours postoperatively", "description"=>"Platelet-to-lymphocyte ratio"}, {"measure"=>"Quadriceps muscle strength assessed using medical research council scale [range 0:5]", "timeFrame"=>"24 hours after surgery", "description"=>"Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Knee Osteoarthritis", "Knee Pain Chronic", "Knee Arthritis"]}, "descriptionModule"=>{"briefSummary"=>"Effect of Erector Spinae Plane Block and iPACK block with Adductor Canal Block on pain management, and NLR and PLR following knee arthroplasty", "detailedDescription"=>"Knee arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.\n\nIn recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with ASA classification I-III,\n* Aged 20-100 years,\n* scheduled for knee arthroplasty under spinal anaesthesia\n\nExclusion Criteria:\n\n* Patients who have a history of bleeding diathesis,\n* Take anticoagulant therapy,\n* have a History of chronic pain before surgery,\n* have Multiple trauma,\n* cannot assess their pain (dementia),\n* have been operated on under general anaesthesia,\n* have an infection in the area\n* do not accept the procedure"}, "identificationModule"=>{"nctId"=>"NCT06233630", "briefTitle"=>"Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty", "organization"=>{"class"=>"OTHER", "fullName"=>"Poznan University of Medical Sciences"}, "officialTitle"=>"Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty", "orgStudyIdInfo"=>{"id"=>"4/2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Only spinal anaesthesia - No peripheral nerve block", "interventionNames"=>["Drug: Control Test - spinal anesthesia"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Erector Spinae Plane Block", "description"=>"spinal anaesthesia and unilateral ultrasound guided erector spinae plane block - 20ml 0.2% ropivacaine", "interventionNames"=>["Drug: Ropivacaine 0.2% Injectable Solution ESPB"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block", "description"=>"spinal anaesthesia and ultrasound guided Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee (iPACK) block - 20ml 0.2% ropivacaine\n\n+ ultrasound guided Adductor Canal Block - 10ml 0.2% ropivacaine", "interventionNames"=>["Drug: Ropivacaine 0.2% Injectable Solution iPACK+ACB"]}], "interventions"=>[{"name"=>"Control Test - spinal anesthesia", "type"=>"DRUG", "otherNames"=>["spinal anesthesia"], "description"=>"No peripheral nerve block Only spinal anesthesia", "armGroupLabels"=>["Placebo"]}, {"name"=>"Ropivacaine 0.2% Injectable Solution ESPB", "type"=>"DRUG", "otherNames"=>["erector spinae plane block"], "description"=>"ultrasound guided erector spinae plane block (ESPB) - L2 level, unilateral", "armGroupLabels"=>["Erector Spinae Plane Block"]}, {"name"=>"Ropivacaine 0.2% Injectable Solution iPACK+ACB", "type"=>"DRUG", "otherNames"=>["iPACK+ACB"], "description"=>"ultrasound guided iPACK block + Adductor Canal Block", "armGroupLabels"=>["Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Poznań", "country"=>"Poland", "facility"=>"Poznan University of Medical Sciences", "geoPoint"=>{"lat"=>52.40692, "lon"=>16.92993}}], "overallOfficials"=>[{"name"=>"Malgorzata Domagalska, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Poznan University of Medical Science"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Poznan University of Medical Sciences", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
