Sacral ESP block versus dorsal penile nerve block for pain after pediatric hypospadias surgery
Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Nerve Block on Postoperative Pain Management in Pediatric Patients Undergoing Hypospadias Surgery
This tests whether a sacral erector spinae plane (ESP) block or a dorsal penile nerve block gives better pain relief for boys ages 1–7 having hypospadias surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | Male |
| Sponsor | Medipol University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07426731 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-blind trial enrolling 70 boys aged 1–7 undergoing elective hypospadias repair at Istanbul Medipol University. Under general anesthesia patients will be randomized to receive either an ultrasound-guided sacral ESP block or a dorsal penile nerve block, each using 0.25% bupivacaine at 0.4 mL/kg. Pain will be measured with the FLACC scale at 30 minutes, 1, 2, 6, 12, and 24 hours, with the 12-hour FLACC score as the primary outcome and total analgesic consumption and time to first rescue analgesic as secondary outcomes. The trial aims to determine whether sacral ESP provides superior or non-inferior postoperative analgesia compared with the standard dorsal penile nerve block.
Who should consider this trial
Good fit: Boys aged 1–7 years with ASA physical status I–II scheduled for elective hypospadias surgery whose parents or guardians can provide informed consent are the intended participants.
Not a fit: Children with bleeding disorders, local infection at the injection site, known allergy to local anesthetics, congenital spinal anomalies, neurological/developmental delay, or significant liver or kidney dysfunction would be excluded and may not benefit from this protocol.
Why it matters
Potential benefit: If successful, the sacral ESP block could provide better or longer-lasting pain relief and reduce the need for additional pain medication after hypospadias surgery.
How similar studies have performed: Dorsal penile nerve block is a well-established standard for hypospadias analgesia, while sacral ESP block is a newer, emerging technique with limited but promising pediatric and adult case series and small trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric male patients aged 1-7 years. * ASA (American Society of Anesthesiologists) physical status I or II. * Scheduled for elective hypospadias surgery. * Written informed consent obtained from parents/guardians Exclusion Criteria: * History of neurological deficit or developmental delay. * Bleeding diathesis or known coagulopathy. * History of allergy to local anesthetics. * Infection or skin lesion at the block injection site. * Congenital spinal anomaly. * Mental retardation or history of psychiatric disease. * Liver or kidney dysfunction
Where this trial is running
Istanbul
- Istanbul Medipol University — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Burak Ömür
- Email: bomur@medipol.edu.tr
- Phone: +905056215056
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.