Nctid:
NCT06221150
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000006330", "term"=>"Heart Defects, Congenital"}], "ancestors"=>[{"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000018376", "term"=>"Cardiovascular Abnormalities"}, {"id"=>"D000000013", "term"=>"Congenital Abnormalities"}], "browseLeaves"=>[{"id"=>"M9419", "name"=>"Heart Diseases", "asFound"=>"Heart Disease", "relevance"=>"HIGH"}, {"id"=>"M9418", "name"=>"Heart Defects, Congenital", "asFound"=>"Congenital Heart Disease", "relevance"=>"HIGH"}, {"id"=>"M12", "name"=>"Congenital Abnormalities", "relevance"=>"LOW"}, {"id"=>"M20503", "name"=>"Cardiovascular Abnormalities", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M5315", "name"=>"Bupivacaine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-05", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Postoperative Fentanyl consumption", "timeFrame"=>"24 hours"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Congenital Heart Disease"]}, "descriptionModule"=>{"briefSummary"=>"The serratus anterior plane block (SAPB) is an anterolateral thoracic wall block that was described in 2013 by Blanco et al. who presented it as an alternative to other regional anesthetic techniques. It has been described in adults as an adjunct to general anesthesia or as a primary anesthetic technique for breast surgery, it has not been widely utilized as a primary anesthetic technique in the pediatric population. It was designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax. It provides a viable alternative to paravertebral blockade and central neuraxial block in this patient population The investigators believe that the bilateral two-level injection technique may provide effective analgesia as its efficacy was not properly investigated in corrective heart surgeries with median sternotomy in the pediatric population."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"6 years", "minimumAge"=>"6 months", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Risk Adjustment for Congenital Heart Surgery (RACHS) category 1,2 and 3 Pediatric patients undergoing corrective congenital cardiac surgeries via a median sternotomy\n\nExclusion Criteria:\n\n* • Refusal of legal guardian.\n\n * Patient with congestive heart failure .\n * Patient weaned from cardiopulmonary bypass on high doses of inotropic support (Adrenaline or noradrenaline more than 200ng/kg/min).\n * Patient undergoing Redo cardiac surgery.\n * Known allergy to local anesthetics.\n * Infection at injection site.\n * Bleeding disorders (drug induced i.e., coumadin; or genetic i.e. hemophilia; or acquired i.e. DIC), coagulopathy: PTT \\> 40 seconds, INR \\> 1.4, platelet count \\< 100x10⁹.\n * severe renal or hepatic insufficiency.\n * Neurological disorders because it will be difficult to assess their pain score (e.g. cerebral palsy)."}, "identificationModule"=>{"nctId"=>"NCT06221150", "briefTitle"=>"Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Ultrasound-guided Bilateral Two Levels Serratus Anterior Plane Block in Pediatric Cardiac Surgery With Median Sternotomy : A Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"MD-341-2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"SAPB group", "interventionNames"=>["Procedure: Bilateral two level serratus anterior block"]}, {"type"=>"NO_INTERVENTION", "label"=>"control"}], "interventions"=>[{"name"=>"Bilateral two level serratus anterior block", "type"=>"PROCEDURE", "description"=>"A bilateral two-level SAPB will be performed with the guidance of ultrasound. While the patient is in the supine position with their arms abducted, the ribs will be counted down from the second rib at the level of manubriosternal joint, the mid- axillary line will be demarcated where the probe will be placed in the longitudinal plane to visualize the ribs and the overlying muscles. Using in- plane approach, a 22-gauge short bevel needle will be inserted and advanced to the plane between the latissimus dorsi muscle and the serratus muscle under sono-visualization at the level of 3rd and 6th ribs bilaterally in succession over which a total volume of 1ml/kg bupivacaine 0.25% will be divided and injected (0.5ml/kg on each side); with total dose not exceeding 2.5 mg/kg", "armGroupLabels"=>["SAPB group"]}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate professor", "investigatorFullName"=>"Mai Madkour", "investigatorAffiliation"=>"Cairo University"}}}}
