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Completed

NCT Number: NCT07615335

Comparison Between Ultrasound Guided Caudal Block and Ultrasound Guided Dorsal Penile Block in Hypospadias Surgery in Children

The study focuses on comparing the caudal block (CB) and the dorsal penile nerve block (DPNB) via ultrasound guidance in regional anesthesia in hypospadias surgery.

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Key information

Conditions

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

Age range

1 year–6 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University Hospitals

Kafr ash Shaykh, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • It included male children who underwent hypospadias surgery (distal or mid penile) from 1 to 6 years old with American Society of Anesthesiologists (ASA) classification 1 or 2.

Exclusion criteria

  • children older than 6 years and younger than 1 year.
  • children with neurological, mental, and intellectual problems
  • bleeding tendency
  • allergy to any local anesthesia
  • contraindications to regional anesthesia, back anomalies
  • liver diseases.

Treatment and study plan

Caudal Block Anesthesia

Procedure

Patients were positioned laterally for the procedure. The ultrasound transducer was first positioned transversely at the midline to visualize the sacral cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus in a transverse view. It was then rotated 90° to obtain a longitudinal view of the sacrococcygeal ligament and sacral hiatus. A 22G, 50 mm needle was inserted caudal to cranial into the sacral canal under direct real-time longitudinal ultrasound guidance

Dorsal Penile Block Anesthesia

Procedure

With the patient in a supine position, using aseptic precautions, a linear probe (6-13 MHz) was placed transversely at the root of the penis. The penis was held under gentle traction, and key anatomical structures, including the corpus cavernosum, corpus spongiosum, dorsal artery and vein, Buck's fascia, and tunica albuginea, were identified in the transverse plane

Primary outcomes

  1. Time to first rescue analgesia in hours

    Time frame: From surgery time to the next day after surgery.

    The time interval (measured in hours) from a specific starting point until the patient requires their first dose of additional pain medication (the "rescue" dose).

  2. Intraoperative Fentanyl dose

    Time frame: During the operations

Sponsors and collaborators

Lead sponsor

Ahmed Aouf

Other

Registry information

Official study title

Comparison Between Ultrasound Guided Caudal and Dorsal Penile Block After Hypospadias Surgery in Children, A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jun 2, 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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