[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629456":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":50,"responsibleParty":67,"collaborators":30,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":30,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":30,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Poznan University of Medical Sciences","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Dexamethasone + Perineural Placebo","ACTIVE_COMPARATOR","Brachial plexus block with ropivacaine + dexamethasone IV 0.1 mg\u002Fkg (max 8 mg) and perineural 0.9% NaCl.",[13],"Drug: iv dexamethasone",{"label":15,"type":10,"description":16,"interventionNames":17},"Perineural Dexamethasone + Intravenous Placebo","Brachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg\u002Fkg (max 4 mg) and IV 0.9% NaCl.",[18],"Drug: pn dexamethasone",{"label":20,"type":10,"description":21,"interventionNames":22},"Placebo (IV + Perineural)","Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally.",[23],"Drug: 0.9%NaCl",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","iv dexamethasone","Participants in this arm will receive intravenous dexamethasone at a dose of 0.1 mg\u002Fkg (maximum 8 mg) administered immediately before the brachial plexus block. A perineural placebo (0.9% normal saline) will be added to the local anesthetic syringe for the nerve block in order to maintain blinding.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"pn dexamethasone","Participants in this arm will receive dexamethasone administered perineurally at a dose of 0.1 mg\u002Fkg (maximum 4 mg) mixed with the local anesthetic solution for the brachial plexus block. An intravenous placebo (0.9% normal saline) will be administered immediately before the block to maintain blinding.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"0.9%NaCl","Participants in this arm will receive placebo both intravenously and perineurally. Normal saline will be added to the local anesthetic solution for the brachial plexus block and administered intravenously in volumes matching the active treatment groups in order to maintain blinding.",[20],[40],{"name":41,"affiliation":5,"role":42},"Malgorzata Reysner, MD PhD","STUDY_CHAIR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Malgorzata Reysenr, MD PhD","CONTACT","48618738313","mreysner@ump.edu.pl",{"name":41,"role":46,"phone":47,"phoneExt":30,"email":48},[51],{"facility":5,"status":52,"city":53,"state":30,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Poznan","62-701","Poland","PL",{"type":58,"coordinates":59},"Point",[60,61],16.92993,52.40692,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":66,"phoneExt":30,"email":48},"Malgorzata Reysner, M.D. Ph.D.","+48 61 873 83 03",{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100629456","perineural-vs-intravenous-dexamethasone-as-an-adjuvant-to-brachial-plexus-block-in-pediatric-hand-surgery-100629456",false,"NCT07474909","Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery","Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment","Inclusion Criteria:\n\n* Age 3 months to 16 years\n* Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block\n* ASA physical status I-III\n* Planned use of ultrasound-guided regional anesthesia\n* Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child\n\nExclusion Criteria:\n\n* Pre-existing neurological disease or peripheral neuropathy\n* Preoperative sensory deficit in the operative limb\n* Infection at or near the needle insertion site\n* Coagulopathy or therapeutic anticoagulation\n* Systemic infection or sepsis\n* Chronic steroid therapy within 30 days before surgery\n* Known allergy to ropivacaine or dexamethasone\n* Diabetes mellitus\n* BMI \\> 99th percentile for age and sex.\n* Pregnancy or breastfeeding\n* Participation in another interventional clinical trial within 30 days\n* Refusal of consent","ALL","3 Months","16 Years",{"count":80,"type":81},150,"ESTIMATED","INTERVENTIONAL",[84],"NA","This clinical trial will evaluate the neurological safety and analgesic effectiveness of dexamethasone administered perineurally or intravenously as an adjuvant to brachial plexus block in children undergoing hand or forearm surgery. Dexamethasone is commonly used to prolong the duration of regional anesthesia, but there is limited evidence on long-term neurological safety, particularly in pediatric patients.\n\nAll participants will receive a single-shot brachial plexus block using ropivacaine under ultrasound guidance. Patients will be randomized into one of three treatment groups:\n\nperineural dexamethasone, intravenous dexamethasone, or placebo. The primary objective is to determine whether perineural dexamethasone causes any clinically significant nerve injury compared with intravenous administration or placebo. Neurological function will be assessed clinically and via serum neurofilament light chain (NfL) levels over a 12-month follow-up period.\n\nThis study may provide evidence regarding the long-term safety profile of perineural dexamethasone in children and help establish evidence-based dosing and administration guidelines.",[87,88],"Hand Injuries and Disorders","Wrist Sprain","2026-05-20",{"date":91,"type":92},"2026-05-22","ACTUAL",{"date":94,"type":92},"2025-12-10",{"date":96,"type":81},"2027-01-31",{"name":5,"class":6},1]