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Caudal Anesthesia Versus Local Anesthesia in Hypospadias

NCT06417060 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-20

No results posted yet for this study

Summary

Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair.

Conditions

  • Hypospadias
  • Hypospadias, Coronal
  • Caudal Anesthesia
  • Children

Interventions

DRUG

Caudal block anesthesia

Anesthesia will be administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.

DRUG

Dorsal penile block anesthesia

Anesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis.

Sponsors & Collaborators

  • Necmi Kadıoğlu Hospital

    lead OTHER

Principal Investigators

  • Mustafa Azizoğlu · Necmi Kadıoğlu State Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
48 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2024-08-29
Completion
2024-08-30

Countries

  • North Macedonia
  • Russia
  • 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 NCT06417060 on ClinicalTrials.gov