Actively Recruiting
Impact of Caudal Block Versus Dorsal Penile Block Anesthesia on Postoperative Complications in Distal Hypospadias Surgery: A Multi-Center Randomized Controlled Trial
Led by Necmi Kadıoğlu Hospital · Updated on 2024-08-20
200
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypospadias is a common genital malformation in boys that is usually treated with surgery. Researchers are evaluating whether caudal anesthesia compared to dorsal penile block anesthesia affects the rate of surgical complications like urethrocutaneous fistulas and glans dehiscence after hypospadias repair. This pilot randomized controlled trial aims to determine if one anesthesia method leads to fewer complications and to test the feasibility of a larger study. Participants aged 6 to 48 months undergoing distal hypospadias repair will be randomly assigned to receive either a caudal block or a dorsal penile block anesthesia. Both methods use inhalation induction with air/nitrous oxide and sevoflurane followed by an injection of bupivacaine without epinephrine. Additional pain management includes fentanyl, dexamethasone, ondansetron, acetaminophen, morphine, and post-discharge medications such as oral morphine, Ditropan, Tylenol, ibuprofen, and trimethoprim until catheter removal. During the study, children will be closely monitored for postoperative complications for up to one year. Researchers will assess safety and complication rates, medication usage, and recovery progress. This double-blind, randomized trial will provide detailed data on the impact of anesthesia type on surgical outcomes and help guide future treatment decisions.
CONDITIONS
Brief Title
Caudal Anesthesia Versus Local Anesthesia in Hypospadias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 6 and 48 months
- Distal hypospadias diagnosis
- Acceptance of participation
You will not qualify if you...
- Midpenile hypospadias
- Proximal hypospadias
- Prior surgery for hypospadias
- Comorbid conditions such as diabetes, hypertension, or cardiac pathology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge after surgery
Participants undergo hypospadias repair surgery under anesthesia with either caudal block or dorsal penile block, with standardized analgesic administration.
1 surgical visit
Duration - Up to 1 year
Participants are followed for postoperative complications and recovery, with medication administered as needed by parents.
Approximately 6 post-operative visits
Trial Site Locations
Total: 3 locations
1
Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia
Skopje, North Macedonia
Actively Recruiting
2
Ao Gk Medsi
Moscow, Russia
Actively Recruiting
3
Necmi Kadioglu Esenyurt State Hospital
Istanbul, Turkey (Türkiye), 34430
Actively Recruiting
Research Team
M
Mustafa Azizoğlu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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