Actively Recruiting
Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
Led by Tanta University · Updated on 2025-09-09
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Parent or guardian refusal of participation
- Coagulopathy or current anticoagulant therapy
- Infection at the intended injection site (sacral/caudal region) or systemic infection
- Allergy or 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 contraindicates caudal block or sacral ESPB or could interfere with safe participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tanta University Hospital
Tanta, El-Gharbia Govenorate, Egypt, 31527
Actively Recruiting
Research Team
G
Ghada MA Elfekey, MBBCH
CONTACT
M
Marwa A Eloraby, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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