Caudal Anesthesia Versus Local Anesthesia in Hypospadias

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-48
SponsorNecmi Kadıoğlu Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 6 and 48 months

Distal hypospadias

Acceptance of participation

Disqualifiers

Midpenil hypospadias

Proximal hypospadias

Prior surgery

Comorbidity (diabetes, hypertention, cardiac pathology)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caudal block anesthesia

    Drug

    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.

  • Dorsal penile block anesthesia

    Drug

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Caudal blockExperimental treatment 1 intervention
Group B: Dorsal Penile Block AnesthesiaSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative complication rate

A urethrocutaneous fistula (UCF) is characterized by an abnormal connection between the reconstructed urethra and the skin, situated between the original meatus and the tip of the penis. Glans dehiscence refers to the complete separation of the glans wings, which may or may not be connected by a strip of skin.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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