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Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery

RecruitingNAAges 1 Year - 5 YearsMaleTanta University
NCT07099560 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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/kg; 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/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative car

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📋 Eligibility rules (as published)
Inclusion Criteria * Male children aged 1-5 years * ASA physical status I-II * Scheduled for elective hypospadias repair under general anesthesia * Parent or legal guardian provides written informed consent * Able to complete postoperative assessments through 24 hours after surgery Exclusion Criteria * Parent/guardian refusal of participation * Coagulopathy or current anticoagulant therapy * Infection at the intended injection site (sacral/caudal region) or systemic infection * Allergy/hypersensitivity to amide local anesthetics (e.g., bupivacaine) or study medications * Neurologic or spinal disorders or congenital sacral anomalies affecting block safety * Significant hepatic, renal, or cardiac disease * Any other condition that, in the investigator's judgment, contraindicates caudal block or sacral ESPB or could interfere with safe participation
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What it tests

  • Ultrasound-guided sacral erector spinae plane block (sESPB)
  • Ultrasound-guided caudal epidural block
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Where

1 site
Tanta University Hospital
Tanta, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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