RecruitingNot ApplicableNCT06417060

Caudal Anesthesia Versus Local Anesthesia in Hypospadias

THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL


Sponsor

Necmi Kadıoğlu Hospital

Enrollment

200 participants

Start Date

May 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 6 MonthsMax Age: 48 Months

Inclusion Criteria3

  • Aged between 6 and 48 months
  • Distal hypospadias
  • Acceptance of participation

Exclusion Criteria4

  • Midpenil hypospadias
  • Proximal hypospadias
  • Prior surgery
  • Comorbidity (diabetes, hypertention, cardiac pathology)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCaudal 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.

DRUGDorsal 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.


Locations(3)

Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia

Skopje, North Macedonia

Ao Gk Medsi

Moscow, Russia

Necmi Kadioglu Esenyurt State Hospital

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06417060


Related Trials