[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600597":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":74,"collaborators":45,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":45,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":45,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":54,"whyStopped":45,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Sacral Erector Spinae Plane Block (sESPB)","EXPERIMENTAL","Participants receive bilateral ultrasound-guided sacral ESPB after induction of general anesthesia. Using a high-frequency linear probe, the needle is advanced to the sacral fascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL\u002Fkg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue analgesia (pethidine 0.5 mg\u002Fkg) if FLACC ≥4.",[13],"Procedure: Ultrasound-guided sacral erector spinae plane block (sESPB)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B - Active Comparator: Caudal Epidural Block","Participants receive ultrasound-guided caudal epidural block after induction of general anesthesia. Needle introduced via the sacral hiatus under ultrasound; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL\u002Fkg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.",[18],"Procedure: Ultrasound-guided caudal epidural block",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Ultrasound-guided sacral erector spinae plane block (sESPB)","After induction of general anesthesia, bilateral sESPB is performed under ultrasound guidance. Needle advanced to the sacral interfascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL\u002Fkg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine 0.5 mg\u002Fkg if FLACC ≥4.",[9],[26,27],"sESPB","sacral ESP block",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ultrasound-guided caudal epidural block","After induction of general anesthesia, caudal epidural injection via sacral hiatus under ultrasound guidance; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL\u002Fkg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.",[15],[33,34,35],"Caudal epidural block (CEB)","Caudal epidural anesthesia","Caudal block",[37],{"name":38,"affiliation":39,"role":40},"Ghada MA Elfekey, MBBCH","Faculty of Medicine, Tanta University, Egypt","PRINCIPAL_INVESTIGATOR",[42,47],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","+201271600557",null,"ghadaelfekey0@gmail.com",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Marwa A Eloraby, MD","+201008618309","marwa.elfert@med.tanta.edu.eg",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Tanta University Hospital","RECRUITING","Tanta","El-Gharbia Govenorate","31527","Egypt","EG",{"type":61,"coordinates":62},"Point",[63,64],31.00192,30.78847,{"lat":64,"lon":63},[67,70,72],{"name":68,"role":69,"phone":45,"phoneExt":45,"email":45},"Marwa A ELoraby, MD","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":45,"phoneExt":45,"email":45},"Gehan M Eid, MD",{"name":73,"role":69,"phone":45,"phoneExt":45,"email":45},"Osama M Shalaby, MD",{"type":40,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Ghada Magdy Ahmed Elfekey","Resident of Anesthesia, Surgical Intensive Care and Pain Management","100600597","ultrasound-guided-sacral-erector-spinae-plane-block-versus-ultrasound-guided-caudal-block-in-pediatric-undergoing-hypospadias-surgery-100600597",false,"NCT07099560","Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery","Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery","Inclusion Criteria\n\n* Male children aged 1-5 years\n* ASA physical status I-II\n* Scheduled for elective hypospadias repair under general anesthesia\n* Parent or legal guardian provides written informed consent\n* Able to complete postoperative assessments through 24 hours after surgery Exclusion Criteria\n* Parent\u002Fguardian refusal of participation\n* Coagulopathy or current anticoagulant therapy\n* Infection at the intended injection site (sacral\u002Fcaudal region) or systemic infection\n* Allergy\u002Fhypersensitivity to amide local anesthetics (e.g., bupivacaine) or study medications\n* Neurologic or spinal disorders or congenital sacral anomalies affecting block safety\n* Significant hepatic, renal, or cardiac disease\n* Any other condition that, in the investigator's judgment, contraindicates caudal block or sacral ESPB or could interfere with safe participation","MALE","1 Year","5 Years",{"count":88,"type":89},70,"ESTIMATED","INTERVENTIONAL",[92],"NA","Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL\u002Fkg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent\u002Fguardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.",[95,96,97,98],"Hypospadias","Caudal Block","Erector Spinae Plane Block","Pain, Postoperative",[100,101,102,103,104,105],"hypospadias","nerve block","erector spinae plane block","caudal block","pain","ultra-sound","2025-09-06",{"date":108,"type":109},"2025-09-09","ACTUAL",{"date":111,"type":109},"2025-04-01",{"date":113,"type":89},"2026-04",{"name":5,"class":6},1]