Caudal Anesthesia Versus Local Anesthesia in Hypospadias

THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL

Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair.

Study Overview

• Status: Recruiting
• Conditions: Children; Hypospadias; Hypospadias, Coronal; Caudal Anesthesia
• Intervention / Treatment: Drug: Caudal block anesthesia; Drug: Dorsal penile block anesthesia

Detailed Description

The rationale for conducting a comprehensive study arises from the limitations inherent in existing literature, primarily due to selection bias and the retrospective nature of current evidence, which fails to clarify whether caudal blocks lead to higher complication rates after hypospadias repair. To fill this knowledge gap and address the clinical uncertainty surrounding this issue, the only effective approach is to randomly assign patients undergoing hypospadias repair to receive either caudal or penile block anesthesia. The purpose of this pilot study is to evaluate the feasibility of a definitive trial and identify any methodological issues that must be resolved before committing significant resources to a full-scale study.

This pilot study will assess the feasibility of conducting a large, definitive, parallel-group, randomized controlled trial (RCT) to determine whether a dorsal penile block results in fewer postoperative complications than a caudal block in boys aged 6 to 48 months undergoing hypospadias repair.

Hypospadias repair will be performed under standardized analgesic administration, and participants may receive fentanyl (1-3 mcg/kg) at the anesthesiologist's discretion. Anesthesia will be induced via inhalation of air/nitrous oxide and sevoflurane. Based on a randomized allocation, patients will receive either a caudal anesthetic block (0.25% bupivacaine, 1 ml/kg, up to a maximum of 10 ml) or a dorsal penile block (bupivacaine without epinephrine, 10-20 ml/kg). All patients will receive antiemetic prophylaxis with dexamethasone (150 mcg/kg), ondansetron (50 mcg/kg), acetaminophen suppository (40 mg/kg), and intravenous morphine (0.02-0.1 mg/kg).

At discharge, patients will be prescribed oral morphine (0.2 mg/kg) every 4 hours as needed, Ditropan (0.2 mg/kg) every 12 hours as needed, Tylenol (15 mg/kg per dose) every 4 hours, or ibuprofen (10 mg/kg per dose) every 6 hours. Parents will administer these medications at their discretion. Trimethoprim (2 mg/kg) will also be prescribed until catheter removal.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa Azizoğlu, MD, PhD; Phone Number: +905447448244; Email: mdmazizoglu@gmail.com

Study Locations

• North Macedonia
  • Skopje, North Macedonia
    • Recruiting
    • Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia
    • Contact: Toni Risteski
    • Principal Investigator: Toni Risteski
• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Ao Gk Medsi
    • Contact: Sergey Klyuev, MD
    • Principal Investigator: Sergey Klyuev, MD
• Turkey
  • Istanbul, Turkey, 34430
    • Recruiting
    • Necmi Kadioglu Esenyurt State Hospital
    • Contact: Mustafa Azizoğlu; Phone Number: +905447448244; Email: mdmazizoglu@gmail.com
    • Principal Investigator: Mustafa Azizoglu, MD, PhD

Participation Criteria

Eligibility Criteria

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

Description

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)

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: Caudal block; Anesthesia will be administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.	Drug: Caudal block anesthesia; Anesthesia will be administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.
Sham Comparator: Dorsal Penile Block Anesthesia; Anesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis.	Drug: Dorsal penile block anesthesia; Anesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complication rate	A urethrocutaneous fistula (UCF) is characterized by an abnormal connection between the reconstructed urethra and the skin, situated between the original meatus and the tip of the penis. Glans dehiscence refers to the complete separation of the glans wings, which may or may not be connected by a strip of skin.	1 year

Collaborators and Investigators

• Sponsor: Necmi Kadıoğlu Hospital
• Investigators: Principal Investigator: Mustafa Azizoğlu, Necmi Kadıoğlu State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): May 25, 2024
• Study Completion (Estimated): May 26, 2024

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hypospadias; Caudal anesthesia; Urethrocutanous fistula
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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