Sacral erector spinae plane block versus caudal epidural block for pain after hypospadias repair in young boys

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel-group, assessor-blinded trial at Tanta University Hospital comparing ultrasound-guided sacral erector spinae plane block (sESPB) with ultrasound-guided caudal epidural block for postoperative analgesia in male children undergoing hypospadias repair. Seventy participants aged 1–5 will be randomized 1:1 to receive either 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 measured with 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 events. Perioperative care is standardized and rescue pethidine is given when FLACC ≥4 to manage breakthrough pain.

Why it matters

Who can join: the full rules

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

Where it's running

• Tanta University Hospital
  Tanta, El-Gharbia Govenorate, Egypt Recruiting

Study contacts

• Principal investigator: Ghada MA Elfekey, MBBCH — Faculty of Medicine, Tanta University, Egypt
• Study coordinator: Ghada MA Elfekey, MBBCH
• Email: ghadaelfekey0@gmail.com
• Phone: +201271600557

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.