NCT07426731

Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Medipol University · Academic / Other
• Sex: Male
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour

Detailed description

Hypospadias surgery in pediatric patients can cause significant postoperative pain. While Dorsal Penile Nerve Block (DPNB) is a standard regional technique, the Sacral Erector Spinae Plane (ESP) block has emerged as a potential alternative for trunk and pelvic analgesia. In this prospective, randomized, double-blind study, 70 pediatric patients (ASA I-II, aged 1-7 years) will be randomly assigned to receive either a Sacral ESP block or a DPNB under general anesthesia. Both blocks will be performed under ultrasound guidance using 0.25% bupivacaine, administered at a volume of 0.4 mL/kg for the Sacral ESP block and 0.4 mL/kg for the DPNB. Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, 1, 2, 6, 12, and 24 hours. The study aims to determine if Sacral ESP provides superior or non-inferior analgesia compared to DPNB, specifically focusing on the 12th-hour pain scores, total analgesic consumption, and time to first rescue analgesic

Conditions

• Postoperative Pain
• Hypospadias

Interventions

Type	Name	Description
PROCEDURE	Sacral ESP Block Group	Patients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
PROCEDURE	Dorsal Penile Nerve Block Group	Patients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally

Timeline

• Start date: 2026-02-13
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2026-02-23
• Last updated: 2026-03-20

Locations

1 site across 1 country: Turkey (Türkiye)