Caudal Anesthesia Versus Local Anesthesia in Hypospadias

NCT06417060 | Recruiting DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Hypospadias; Caudal anesthesia; Urethrocutanous fistula

Outcome Measures

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.

  1 year

Study Arms (2)

Caudal block

EXPERIMENTAL

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: Caudal block anesthesia

Dorsal Penile Block Anesthesia

SHAM COMPARATOR

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.

Drug: Dorsal penile block anesthesia

Interventions

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.

Caudal block

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.

Dorsal Penile Block Anesthesia

Eligibility Criteria

• Age: 6 Months - 48 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Necmi Kadıoğlu Hospital: lead

Study Sites (3)

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

Skopje, North Macedonia

RECRUITING

Ao Gk Medsi

Moscow, Russia

RECRUITING

Necmi Kadioglu Esenyurt State Hospital

Istanbul, 34430, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mustafa Azizoğlu

  Necmi Kadıoğlu State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Azizoğlu, MD, PhD

CONTACT

+905447448244; mdmazizoglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant and outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: May 25, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1); TU (1); NO (1)