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

NCT07286786 | Completed

• 1 other identifier: CemilTasciogluDr.Kankal
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group C (caudal block)

Group

Procedure: Caudal Block Anesthesia

Group S (sacral ESP block)

Cohort

Procedure: Erector Spinae Plane Block

Interventions

Caudal Block Anesthesia 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 C (caudal block)

Erector Spinae Plane Block 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.

Group S (sacral ESP block)

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residents in Anesthesiology

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: January 18, 2025
• Primary Completion: August 18, 2025
• Study Completion: September 15, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-10

Locations

TU (1)