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Comparison of Analgesic Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Block in Pediatric Patients Undergoing Hypospadias Surgery

NCT07286786 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2026-01-07

No results posted yet for this study

Summary

The goal of this observational study is to learn about effects of block strategies (sacral erector spinae plane block - ESP, caudal block) on perioperative pain in pediatric patients undergoing hypospadias surgery. The main question it aims to answer is:

Is there a difference in analgesic efficacy between sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias surgery? Eighty six pediatric patients (ages 1-7 years, ASA I-II) scheduled for hypospadias repair under general anesthesia were included in this prospective randomized study. Both blocks were performed using 0.25% bupivacaine, at doses of 0.5 mL/kg for our study. Pain was assessed using the FLACC scale at 1, 2, 4, 6, 12 and 24 hours postoperatively.

Conditions

  • Hypospadias

Interventions

PROCEDURE

Caudal Block Anesthesia

Caudal block, with its simple application system, high success rate (98-100%), and ability to provide reliable analgesia, is a first-line block method for pain control compared to other options, including peripheral blocks. It provides analgesic effects in the dermatomal region between T10 and S5. It is indicated for chronic back care in adults and for painful infraumbilical procedures such as pediatric circulation, hypospadias repair, circumcision, inguinal hernia repair, and anal atresia surgery. Although it is sometimes used as the sole anesthesia method in pediatric surgery, it is generally used in conjunction with general anesthesia. Congenital or therapeutic coagulation disorders should be excluded before application. Contraindications for caudal block in children include local vascular involvement, hairline cysts, and congenital spinal anomalies.

PROCEDURE

Erector Spinae Plane Block

In this block, a local anesthetic agent is injected into the fascial plane of the superficial and deep erector spinae muscle at the distal end of the transverse process of the vertebra. The aim is to block the dorsal and ventral rami of the spinal nerves. This block occurs through four different mechanisms: direct action on nerves in the fascial plane, diffusion into the paravertebral space, systemic absorption, and perforation on nerves in nearby compartments. Because the erector spinae muscle extends along the vertebra, ESPB can be preferred for analgesia in the neck, chest, trunk, and lower and upper extremities. With a single-level block, the local anesthetic agent spreads approximately 3-6 vertebral levels in a cranio-caudal direction. This provides guidance on the level at which the block should be performed, depending on the surgical procedure.

Sponsors & Collaborators

  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    lead OTHER

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-18
Primary Completion
2025-08-18
Completion
2025-09-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286786 on ClinicalTrials.gov