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

NCT ID: NCT07286786

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-18
• Study Completion Date: 2025-09-15

Brief 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.

Detailed Description

Postoperative pain management in pediatric urological surgery, particularly in hypospadias repair, is essential for reducing distress, minimizing analgesic requirements, and promoting early recovery. Caudal epidural block remains the gold standard for postoperative analgesia in this patient population due to its well-established safety and efficacy. However, its limitations-such as the risk of motor block, urinary retention, and unpredictable spread of local anesthetic-have encouraged the exploration of alternative regional techniques.

The sacral erector spinae plane (ESP) block, first described for thoracic and lumbar analgesia, has recently been applied in the sacral region as a novel approach for pediatric surgeries involving the perineum and genital area. The block is technically simpler, avoids the epidural space, and carries a low risk of complications. Nevertheless, data comparing its efficacy with the traditional caudal block in hypospadias surgery remain limited.

This study aimed to compare the analgesic efficacy and safety of sacral ESP block and caudal epidural block in children undergoing hypospadias repair surgery.

Conditions

Hypospadias

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group C (caudal block)

Group

Caudal Block Anesthesia

Intervention Type: PROCEDURE

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.

Group S (sacral ESP block)

Cohort

Erector Spinae Plane Block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children aged 1-7 years
• Classified as ASA physical status I-II
• Scheduled for primary hypospadias repair were enrolled

Exclusion Criteria

• Infection at the injection site
• Coagulopathy
• Spinal anomalies
• Allergy to local anesthetics
• Parental refusal.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role: lead

Responsible Party

Sümeyye

Residents in Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, Şişli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CemilTasciogluDr.Kankal

Identifier Type: -

Identifier Source: org_study_id