NCT07615335

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2.3 years

First QC Date

May 22, 2026

Last Update Submit

May 29, 2026

Conditions

HypospadiasHypospadias, Coronal

Outcome Measures

Primary Outcomes (2)

  • 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).

    From surgery time to the next day after surgery.

  • Intraoperative Fentanyl dose

    During the operations

Study Arms (2)

Dorsal penile nerve block group

ACTIVE COMPARATOR

Patients that had regional anesthesia using dorsal penile nerve block

Procedure: Dorsal Penile Block Anesthesia

Caudal epidural block group

ACTIVE COMPARATOR

Patients that had regional anesthesia using caudal epidural block

Procedure: Caudal Block Anesthesia

Interventions

Caudal Block AnesthesiaPROCEDURE

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

Caudal epidural block group
Dorsal Penile Block AnesthesiaPROCEDURE

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

Dorsal penile nerve block group

Eligibility Criteria

Age1 Year - 6 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University Hospitals

Kafr ash Shaykh, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 40777159BACKGROUND

  • 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.

    PMID: 40385755BACKGROUND

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of General Surgery

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

September 1, 2023

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)