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Caudal vs Local Anesthesia in Hypospadias

NCT02512887 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2023-03-15

No results posted yet for this study

Summary

Hypospadias is one of the most common congenital malformations of the genitalia in boys, and is typically managed by surgical intervention. During pediatric urological surgery, caudal anesthesia is one of the most common regional anesthetic techniques used. Also known as caudal block, it has been shown to be a safe and effective anesthetic technique in children with a low incidence of anesthesia-related complications.While the reported incidence of complications directly associated with caudal block is low, there is scarce and inconclusive evidence on the impact of caudal anesthesia on the incidence of surgical complications. As a result, the objective of this superiority, randomized controlled trial is to assess whether the use of caudal anesthesia, when compared to dorsal penile block, is associated with a higher rate of urethrocutaneous fistulas and glans dehiscence post hypospadias repair.

Conditions

  • Hypospadias

Interventions

DRUG

Caudal Block Anesthesia

Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine 1mL/kg without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.

DRUG

Dorsal Penile Block Anesthesia

Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine without epinephrine into the dorsal portion of the penis.

Sponsors & Collaborators

Principal Investigators

  • Luis Braga, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
48 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02512887 on ClinicalTrials.gov