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

NCT07426731 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-20

No results posted yet for this study

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

Interventions

PROCEDURE

Sacral ESP Block Group

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

Dorsal Penile Nerve Block Group

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

Sponsors & Collaborators

  • Biruni University

    collaborator OTHER

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

    collaborator OTHER

  • Medipol University

    lead OTHER

Principal Investigators

  • Selçuk Alver · Istanbul Biruni University Hospital, Istanbul, Turkey.

  • Volkan Özen · Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2026-04-01
Completion
2026-05-01

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 NCT07426731 on ClinicalTrials.gov