Evaluating Caudal Block Impact on Urethrocutaneous Fistula Following Distal Hypospadias Repair in Boys Aged 6-60 Months

What this Trial Is About

Hypospadias is a common congenital condition in males where the urethral opening is abnormally located on the underside of the penis. This trial evaluates the effect of caudal nerve block, a regional anesthesia technique, on the rate of urethrocutaneous fistula, a frequent and significant complication after surgical repair of distal hypospadias in young boys aged 6 to 60 months. The study is a prospective, multicenter, randomized controlled trial conducted in Turkey to provide evidence on the safety and outcomes of caudal block use in this surgery. Participants are randomly assigned to one of two groups one group receives general anesthesia combined with caudal block using bupivacaine hydrochloride, while the other group receives general anesthesia alone with intravenous analgesics per standard care. The study follows patients for 3 to 6 months after surgery to monitor fistula formation, wound healing, and other complications. Data such as anesthesia and surgery duration, pain scores, analgesic use, and hospital stay length are collected. During the study, patients undergo surgery and receive assigned anesthesia procedures. Researchers assess postoperative pain during the first 24 hours, record any complications up to 3 months after surgery, and track the need for additional pain medication. The main outcome is the incidence of urethrocutaneous fistula within 3 months. Safety and effectiveness of pain control techniques are also evaluated. The total participation includes surgery and follow-up visits for several months postoperatively.

Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair