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NCT Number: NCT07426731

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

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

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Key information

About this study

Hypospadias surgery in pediatric patients can cause significant postoperative pain. While Dorsal Penile Nerve Block (DPNB) is a standard regional technique, the Sacral Erector Spinae Plane (ESP) block has emerged as a potential alternative for trunk and pelvic analgesia.

In this prospective, randomized, double-blind study, 70 pediatric patients (ASA I-II, aged 1-7 years) will be randomly assigned to receive either a Sacral ESP block or a DPNB under general anesthesia. Both blocks will be performed under ultrasound guidance using 0.25% bupivacaine, administered at a volume of 0.4 mL/kg for the Sacral ESP block and 0.4 mL/kg for the DPNB.

Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, 1, 2, 6, 12, and 24 hours. The study aims to determine if Sacral ESP provides superior or non-inferior analgesia compared to DPNB, specifically focusing on the 12th-hour pain scores, total analgesic consumption, and time to first rescue analgesic

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Postoperative Pain Score (FLACC) at 12 Hours

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

    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.

Secondary outcomes

  1. Total Postoperative Analgesic Consumption

    Time frame: 24 hours post-surgery

    The cumulative amount of rescue analgesics (mg) consumed.

  2. Incidence of Postoperative Complications.

    Time frame: Up to 24 hours

    Presence of motor block, urinary retention, hematoma/ecchymosis at injection site, vomiting, or pruritus.

  3. Postoperative Pain Scores (FLACC) at Other Time Points

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burak Ömür

CONTACT

[email protected]

+905056215056

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Collaborators

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

Registry information

Official study title

Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Nerve Block on Postoperative Pain Management in Pediatric Patients Undergoing Hypospadias Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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