[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597683":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":59,"studyPopulation":47,"armGroups":60,"interventions":78,"overallOfficials":90,"centralContacts":95,"locations":100,"responsibleParty":126,"collaborators":47,"id":128,"slug":47,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":47,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":47,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":47,"overallStatus":102,"whyStopped":47,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Poznan University of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":47},[9],{"measure":10,"description":10,"timeFrame":11},"Time to first rescue opioid analgesia","48 hours after surgery",[13,16,20,22,24,26,27,30,31,32,35,36,37,40,41,42,45,46],{"measure":14,"description":15,"timeFrame":11},"Total opioid consumption","Total opioid consumption in milliequivalents of morphine",{"measure":17,"description":18,"timeFrame":19},"NRS","The numeric rating scale (NRS) with zero meaning \"no pain\" and 10 meaning \"the worst pain imaginable.\"","4 hours after surgery",{"measure":17,"description":18,"timeFrame":21},"8 hours after surgery",{"measure":17,"description":18,"timeFrame":23},"12 hours after surgery",{"measure":17,"description":18,"timeFrame":25},"24 hours after surgery",{"measure":17,"description":18,"timeFrame":11},{"measure":28,"description":29,"timeFrame":23},"Nerve damage","Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome",{"measure":28,"description":29,"timeFrame":25},{"measure":28,"description":29,"timeFrame":11},{"measure":33,"description":34,"timeFrame":23},"NLR","Neutrophile-to-lymphocyte ratio",{"measure":33,"description":34,"timeFrame":25},{"measure":33,"description":34,"timeFrame":11},{"measure":38,"description":39,"timeFrame":23},"PLR","Platelet-to-lymphocyte ratio",{"measure":38,"description":39,"timeFrame":25},{"measure":38,"description":39,"timeFrame":11},{"measure":43,"description":44,"timeFrame":23},"glucose","blood glucose levels",{"measure":43,"description":44,"timeFrame":25},{"measure":43,"description":44,"timeFrame":11},null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":54},"QUADRUPLE",[55,56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Pediatric arm surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes.\n\nDexamethasone is an adjuvant in regional anesthesia that prolongs analgesia and mitigates inflammation. However, the optimal administration route of dexamethasone in infraclavicular brachial plexus block for pediatric arm surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.\n\nThis prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the infraclavicular brachial plexus block. All patients will receive standardized spinal anesthesia under mild sedation and infraclavicular brachial plexus block using a local anesthetic at a fixed concentration.\n\nThe primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels.\n\nSafety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.",[61,67,72],{"label":62,"type":63,"description":64,"interventionNames":65},"perinerual dexamethasone","ACTIVE_COMPARATOR","infraclavicular brachial plexus block + perineural dexamethasone",[66],"Drug: perineural dexamethasone",{"label":68,"type":63,"description":69,"interventionNames":70},"intravenous dexamethasone","infraclavicular brachial plexus block + intravenous dexamethasone",[71],"Drug: intravenous dexamethasone",{"label":73,"type":74,"description":75,"interventionNames":76},"0.2ml\u002Fkg 0.2% ropivacaine","PLACEBO_COMPARATOR","infraclavicular brachial plexus block",[77],"Drug: 0.2ml\u002Fkg 0.2% ropivacaine",[79,84,87],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":47},"DRUG","perineural dexamethasone","infraclavicular brachial plexus block with 0.2ml\u002Fkg 0.2% ropivacaine with 0.1mg\u002Fkg perineural dexamethasone",[62],{"type":80,"name":68,"description":85,"armGroupLabels":86,"otherNames":47},"infraclavicular brachial plexus block with 0.2ml\u002Fkg 0.2% ropivacaine with 0.1mg\u002Fkg intravenous dexamethasone",[68],{"type":80,"name":73,"description":88,"armGroupLabels":89,"otherNames":47},"infraclavicular brachial plexus block with 0.2ml\u002Fkg 0.2% ropivacaine",[73],[91],{"name":92,"affiliation":93,"role":94},"Malgorzata Reysner, M.D. Ph.D.","Poznan University of Medicl Sciences","PRINCIPAL_INVESTIGATOR",[96],{"name":92,"role":97,"phone":98,"phoneExt":47,"email":99},"CONTACT","+48 61 873 83 03","mreysner@ump.edu.pl",[101,119],{"facility":5,"status":102,"city":103,"state":47,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"RECRUITING","Poznan","61-701","Poland","PL",{"type":108,"coordinates":109},"Point",[110,111],16.92993,52.40692,{"lat":111,"lon":110},[114,117],{"name":92,"role":97,"phone":115,"phoneExt":47,"email":116},"608762068","mreysenr@ump.edu.pl",{"name":118,"role":97,"phone":47,"phoneExt":47,"email":99},"Małgorzata Reysner, M.D. Ph.D.",{"facility":5,"status":120,"city":103,"state":47,"zip":47,"country":105,"countryCode":106,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"NOT_YET_RECRUITING",{"type":108,"coordinates":122},[110,111],{"lat":111,"lon":110},[125],{"name":92,"role":97,"phone":47,"phoneExt":47,"email":47},{"type":127,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100597683",false,"NCT07061678","The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block","The Effect of Dexamethasone Administration Route in Infraclavicular Brachial Plexus Block for Pediatric Arm and\u002For Hand Surgery","Inclusion Criteria:\n\n* children scheduled for arm\u002Fwrist\u002Fhand surgery\n* body weight \\> 5kg\n\nExclusion Criteria:\n\n* infection at the site of the regional block,\n* coagulation disorders,\n* immunodeficiency,\n* American Society of Anesthesiologists (ASA) physical status of IV or higher,\n* history of regular steroid medication.","ALL","3 Months","6 Years",{"count":138,"type":139},90,"ESTIMATED","INTERVENTIONAL",[142],"PHASE4","This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain and inflammatory response in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate scale at multiple intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time-to-first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric arm surgery.",[145],"Arm","2026-05-06",{"date":148,"type":149},"2026-05-11","ACTUAL",{"date":151,"type":149},"2025-10-01",{"date":153,"type":139},"2026-06-28",{"name":5,"class":6},2]