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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:

• Aged between 6 and 48 months

• Distal hypospadias

• Acceptance of participation

Locations
Other Locations
Russian Federation
Ao Gk Medsi
RECRUITING
Moscow
Turkey
Necmi Kadioglu Esenyurt State Hospital
RECRUITING
Istanbul
Contact Information
Primary
Mustafa Azizoğlu, MD, PhD
mdmazizoglu@gmail.com
+905447448244
Time Frame
Start Date: 2023-05-25
Estimated Completion Date: 2024-08-30
Participants
Target number of participants: 200
Treatments
Experimental: Caudal block
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.
Sham_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Necmi Kadıoğlu Hospital

This content was sourced from clinicaltrials.gov