Hypospadias is one of the most common congenital urogenital anomalies in males, occurring in approximately 1 in every 200-300 male births. It is characterized by abnormal positioning of the urethral meatus on the ventral surface of the penis. Surgical repair is the standard treatment; however, urethrocutaneous fistula formation remains one of the most frequent and clinically significant postoperative complications, potentially requiring reoperation and causing considerable distress to both the patient and the family.
Caudal nerve block is a widely used regional anesthesia technique in pediatric lower abdominal and genitourinary surgery, valued for its high analgesic efficacy, relative ease of application, and low complication profile. However, emerging evidence suggests that caudal block may be associated with an increased incidence of postoperative complications following hypospadias repair, including fistula formation and wound edema. Notably, Kundra et al. (2012) reported a fistula rate of 19.2% in patients who received caudal block, compared to 0% in those who received penile block, raising important questions about the routine use of caudal block in hypospadias surgery.
This prospective, multicenter, randomized controlled trial aims to evaluate the effect of caudal block on the incidence of urethrocutaneous fistula following distal hypospadias repair. A total of 80 male patients aged 6-60 months will be randomized 1:1 to either receive general anesthesia with caudal block or general anesthesia alone. The primary outcome is the incidence of urethrocutaneous fistula. Secondary outcomes include perioperative opioid consumption, postoperative pain scores, analgesic duration, and other surgical complications such as wound dehiscence and urethral stricture. Patients will be followed up for 3-6 months postoperatively. The study will be conducted across four centers in Turkey. Results are expected to provide evidence-based guidance on the role of caudal block in pediatric hypospadias repair.
Male patients aged 6-60 months
Diagnosed with distal hypospadias
Scheduled for elective hypospadias repair
Written informed consent obtained from parent or legal guardian
Age < 6 months or > 60 months
Proximal or non-distal hypospadias
Previous hypospadias repair
Skin lesions at the epidural/caudal injection site
Parallel
Caudal Block
Procedure/SurgeryGeneral anesthesia combined with caudal block administered prior to distal hypospadias repair. Caudal block is performed using bupivacaine hydrochloride as part of standard institutional analgesic protocol.
General Anesthesia without Caudal Block
Procedure/SurgeryGeneral anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol.
Incidence of Urethrocutaneous Fistula
Development of urethrocutaneous fistula following distal hypospadias repair, assessed by clinical examination
Postoperative Pain Scores
Postoperative pain assessed using age-appropriate pain scales (e.g., Visual Analog Scale or FLACC scale, where higher scores indicate worse pain).
Surgical Complications
Incidence of surgery-related complications
Duration of Effective Analgesia
The time from the completion of the surgical/anesthetic procedure until the patient first requests or requires rescue analgesia.
Total Consumption of Rescue Analgesics
The total amount (mg) of rescue analgesic medications required by the patient during the postoperative period.
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Lead sponsor
Dicle University
Sponsor institution
