Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery

NCT07426731 | Recruiting

• 1 other identifier: 149
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Postoperative Pain; Hypospadias

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score (FLACC) at 12 Hours

  Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain.

  30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery

Secondary Outcomes (3)

• Total Postoperative Analgesic Consumption

  24 hours post-surgery

• Incidence of Postoperative Complications.

  Up to 24 hours

• Postoperative Pain Scores (FLACC) at Other Time Points

  30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery

Study Arms (2)

Sacral ESP Block Group

EXPERIMENTAL

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: Sacral ESP Block Group

Dorsal Penile Nerve Block Group

ACTIVE COMPARATOR

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.

Procedure: Dorsal Penile Nerve Block Group

Interventions

Dorsal Penile Nerve Block Group PROCEDURE

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

Dorsal Penile Nerve Block Group

Sacral ESP Block Group PROCEDURE

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

Sacral ESP Block Group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric male patients aged 1-7 years.
• ASA (American Society of Anesthesiologists) physical status I or II.
• Scheduled for elective hypospadias surgery.
• Written informed consent obtained from parents/guardians

You may not qualify if:

• History of neurological deficit or developmental delay.
• Bleeding diathesis or known coagulopathy.
• History of allergy to local anesthetics.
• Infection or skin lesion at the block injection site.
• Congenital spinal anomaly.
• Mental retardation or history of psychiatric disease.
• Liver or kidney dysfunction

Sponsors & Collaborators

• Medipol University: lead
• Biruni University: collaborator
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Hypospadias

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; 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 Officials

• Selçuk Alver

  Istanbul Biruni University Hospital, Istanbul, Turkey.

  STUDY CHAIR

• Volkan Özen

  Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Turkey

  STUDY CHAIR

Central Study Contacts

Burak Ömür

CONTACT

+905056215056; bomur@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 23, 2026
• Study Start: February 13, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)