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CompletedNCT07615335Updated Aug 14, 2026

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

An interventional study of Caudal Block Anesthesia and Dorsal Penile Block Anesthesia in Hypospadias and Hypospadias, Coronal, sponsored by Ahmed Aouf. Completed at 1 site in Egypt. Open to male participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Ahmed Aouf · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Sep 2023, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
1 Year to 6 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Hypospadias
  • Hypospadias, Coronal

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03

In context

Hypospadias

131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.

This study's enrollment of 62 is close to the median of 68 across 102 interventional studies indexed under Hypospadias.

Browse Hypospadias studies →

Lead sponsor

Ahmed Aouf is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    Dorsal penile nerve block group

    Patients that had regional anesthesia using dorsal penile nerve block

    Procedure: Dorsal Penile Block Anesthesia

  • Active comparator
    Caudal epidural block group

    Patients that had regional anesthesia using caudal epidural block

    Procedure: Caudal Block Anesthesia

Interventions

  • ProcedureCaudal Block Anesthesia

    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

  • ProcedureDorsal Penile Block Anesthesia

    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

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What researchers measure

Primary outcomes

  1. Time to first rescue analgesia in hours

    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).

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

  2. Intraoperative Fentanyl dose

    Time frame: During the operations

07

Study locations

1 site
  • Kafrelsheikh University Hospitals
    Kafr ash Shaykh, Egypt
08

References and documents

Publications

  • Lin Z, Shao Y, Li H, Chen Z, Li Y, Wu S, Liu N, Zhang Z. Comparing the analgesic effects of ultrasound-guided caudal block and dorsal penile nerve block in pediatric concealed penis correction surgery: a randomized controlled trial. Front Pediatr. 2025 Jul 24;13:1607309. doi: 10.3389/fped.2025.1607309. eCollection 2025. PubMed 40777159 ↗
  • Kumari S, Kumar M, Sinha M, Singha SK, Gupta H, Dubey R. A Comparison of the Ultrasound-Guided Dorsal Penile Block and Ultrasound-Guided Caudal Epidural Block for Postoperative Analgesia in Children Undergoing Hypospadias Surgery: A Randomized Controlled Study. Cureus. 2025 Apr 16;17(4):e82351. doi: 10.7759/cureus.82351. eCollection 2025 Apr. PubMed 40385755 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07615335
Lead sponsor
Ahmed Aouf
Responsible party
Ahmed Aouf (Assistant Lecturer of General Surgery, Kafrelsheikh University) — Sponsor-investigator
First posted
May 29, 2026
Start date
Sep 1, 2023
Primary completion
Jan 1, 2026
Completion
Feb 1, 2026
Last update
Aug 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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