Comparing caudal anesthesia and local anesthesia for hypospadias surgery in children
THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL
This study is trying to see if using different types of anesthesia during hypospadias surgery in young boys affects their recovery and the chances of complications afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 6 Months to 48 Months |
| Sex | Male |
| Sponsor | Necmi Kadıoğlu Hospital Academic / other |
| Locations | 3 sites (Skopje and 2 other locations) |
| Trial ID | NCT06417060 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of a randomized controlled trial comparing caudal anesthesia to dorsal penile block anesthesia in boys aged 6 to 48 months undergoing hypospadias repair. The study seeks to determine if the type of anesthesia used affects the incidence of postoperative complications, specifically urethrocutaneous fistulas and glans dehiscence. Participants will be randomly assigned to receive either caudal block or dorsal penile block anesthesia, with standardized analgesic administration. The findings will help clarify existing uncertainties in the literature regarding the safety and effectiveness of these anesthetic techniques.
Who should consider this trial
Good fit: Ideal candidates are boys aged 6 to 48 months with distal hypospadias who are willing to participate.
Not a fit: Patients with midpenile or proximal hypospadias, prior surgeries, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complication rates for children undergoing hypospadias repair.
How similar studies have performed: While there is limited conclusive evidence regarding the impact of caudal anesthesia on surgical complications, this approach is novel in the context of hypospadias repair.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 6 and 48 months * Distal hypospadias * Acceptance of participation Exclusion Criteria: * Midpenil hypospadias * Proximal hypospadias * Prior surgery * Comorbidity (diabetes, hypertention, cardiac pathology)
Where this trial is running
Skopje and 2 other locations
- 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, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Mustafa Azizoğlu — Necmi Kadıoğlu State Hospital
- Study coordinator: Mustafa Azizoğlu, MD, PhD
- Email: mdmazizoglu@gmail.com
- Phone: +905447448244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.