NCT07099560 Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
| NCT ID | NCT07099560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tanta University |
| Condition | Hypospadias |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Ghada MA Elfekey, MBBCH
PRINCIPAL INVESTIGATOR
Faculty of Medicine, Tanta University, Egypt
Frequently Asked Questions
Who can join the NCT07099560 clinical trial?
This trial is open to male participants only, aged 1 Year or older, up to 5 Years, studying Hypospadias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07099560 currently recruiting?
Yes, NCT07099560 is actively recruiting participants. Contact the research team at ghadaelfekey0@gmail.com for enrollment information.
Where is the NCT07099560 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT07099560 clinical trial?
NCT07099560 is sponsored by Tanta University. The principal investigator is Ghada MA Elfekey, MBBCH at Faculty of Medicine, Tanta University, Egypt. The trial plans to enroll 70 participants.