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

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.

Study Overview

• Status: Completed
• Conditions: Hypospadias
• Intervention / Treatment: Procedure: Caudal Block Anesthesia; Procedure: Erector Spinae Plane Block

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Şişli
    • Istanbul, Şişli, Turkey (Türkiye), 34384
      • Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study included children with ASA I-II, who will undergo hypospadias surgery under general anesthesia, between 1 and 7 years of age, who have no contraindications for block application, and whose legal guardians agreed to participate in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group C (caudal block); Group	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.
Group S (sacral ESP block); Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pain status of patients in both groups will be evaluated with the FLACC score at postoperative 1, 2, 4, 6, 12 and 24 hours.	FLACC: Face, Leg, Activity, Cry, Consolability. The FLACC score is an observational pain assessment tool used primarily in pediatric patients who are unable to communicate verbally. It evaluates pain based on five behavioral categories: 'Face, Legs, Activity, Cry, and Consolability', each scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates no pain, while 1-3 reflects mild pain, 4-6 moderate pain, and 7-10 severe pain. Higher FLACC scores represent poorer pain control and greater patient discomfort, whereas lower scores suggest effective analgesia and adequate patient comfort. Elevated FLACC scores are clinically significant, as they are associated with increased stress responses, agitation, fluctuations in cardiopulmonary parameters, delayed mobilization, and prolonged recovery in pediatric patients.	It will be evaluated at 1, 2, 4, 6, 12 and 24 hours postoperatively.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2025
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Congenital Abnormalities; Urogenital Abnormalities; Penile Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypospadias
• Other Study ID Numbers: CemilTasciogluDr.Kankal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No