Sacral erector spinae plane block versus caudal epidural block for pain after hypospadias repair in young boys
Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
This trial will see if a sacral erector spinae plane block or a caudal epidural block gives better pain relief for boys aged 1–5 after hypospadias repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 1 Year to 5 Years |
| Sex | Male |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia Govenorate) |
| Trial ID | NCT07099560 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Male children aged 1–5 years with ASA physical status I–II scheduled for elective hypospadias repair whose parent or legal guardian provides written informed consent are ideal candidates.
Not a fit: Children with coagulopathy, infection at the injection site, allergy to amide local anesthetics, neurologic or spinal anomalies, significant hepatic/renal/cardiac disease, or any other contraindication are not eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, sESPB could provide equal or better postoperative pain control with fewer adverse effects and lower opioid needs compared with caudal block.
How similar studies have performed: Caudal epidural block is well established for pediatric genitourinary surgery, while sacral ESPB is a newer regional technique with promising small series but limited direct comparative data in hypospadias repair.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tanta, El-Gharbia Govenorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.