Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair

The Effect of Caudal Block on the İncidence of Urethrocutaneous Fistula After Distal Hypospadias Repair: A Multicentre, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Anesthesia; Hypospadias; Caudal Block
• Intervention / Treatment: Procedure: Caudal Block; Procedure: General Anesthesia without Caudal Block

Detailed Description

This is a prospective, multicenter, randomized controlled trial. Eighty male patients aged 6-60 months undergoing distal hypospadias repair will be enrolled across four centers: Dicle University Faculty of Medicine Hospital, Istanbul Başakşehir Çam ve Sakura City Hospital, Diyarbakır Gazi Yaşargil Training and Research Hospital, and Mardin Training and Research Hospital. Patients will be randomized 1:1 using a simple randomization method with sealed envelope allocation into two groups: Group 1 (caudal block + general anesthesia) and Group 2 (general anesthesia alone). Demographic and clinical data, anesthesia and surgery duration, intraoperative and postoperative analgesic use, pain scores, length of hospital stay, and postoperative complications will be recorded. Patients will be followed for 3-6 months postoperatively for fistula formation, wound dehiscence, and urethral stricture. Statistical analysis will be performed using SPSS v22.0; Student t-test, Mann-Whitney U test, Kruskal-Wallis test, and chi-square test will be applied as appropriate. A p value ≤ 0.05 will be considered statistically significant.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fikret Salık, associate professor; Phone Number: +905076214125; Email: fikretsalik@gmail.com
• Study Contact Backup: Name: Fikret Salık; Phone Number: 05076214125; Email: fikretsalik@gmail.com

Study Locations

• Turkey (Türkiye)
  • Eyalet/Yerleşke
    • Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye), 21070
      • Recruiting
      • Dicle University
      • Contact: Fikret Salık; Phone Number: 05076214125; Email: fikretsalik@gmail.com
    • Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye), 21070
      • Recruiting
      • Gazi Yaşargil Training and Research Hospital
      • Contact: Mustafa Bıçak; Phone Number: 05320571437; Email: drmustafabicak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male patients aged 6-60 months
• Diagnosed with distal hypospadias
• Scheduled for elective hypospadias repair
• Written informed consent obtained from parent or legal guardian

Exclusion Criteria:

• Age < 6 months or > 60 months
• Proximal or non-distal hypospadias
• Previous hypospadias repair
• Skin lesions at the epidural/caudal injection site
• Coagulopathy
• Known allergy to anesthetic agents, particularly bupivacaine hydrochloride
• Spinal anomalies
• Chronic granulomatous disease
• Diabetes mellitus
• Patients receiving corticosteroid therapy
• Refusal of informed consent by parent or guardian

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1) Caudal Block Group; General 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.	Procedure: Caudal Block; General 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.
Active Comparator: Group 2) Non-Caudal Group; General anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol.	Procedure: General Anesthesia without Caudal Block; General anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Urethrocutaneous Fistula	Development of urethrocutaneous fistula following distal hypospadias repair, assessed by clinical examination	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 24 hours postoperatively
Surgical Complications	Incidence of surgery-related complications	Up to 3 months
Duration of Effective Analgesia	The time from the completion of the surgical/anesthetic procedure until the patient first requests or requires rescue analgesia.	Up to 24 hours postoperatively
Total Consumption of Rescue Analgesics	The total amount (mg) of rescue analgesic medications required by the patient during the postoperative period.	Up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Congenital Abnormalities; Urogenital Abnormalities; Penile Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypospadias; Anesthesia and Analgesia; Anesthesia; Anesthesia, General
• Other Study ID Numbers: 357/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No