Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?

Summary

This is a prospective randomized multi-center non-inferiority trial conducted through the Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair compared with penile nerve block.

Conditions

• Hypospadias
• Urethrocutaneous Fistula

Interventions

DRUG

Caudal block with ropivacaine

Patients in this arm will receive a caudal block with ropivacaine

DRUG

penile nerve block with bupivacaine

Patients in this arm will receive a penile block with bupivacaine

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Children's Medical Center of Dallas/UT Southwestern

  collaborator UNKNOWN

• University of Mississippi Medical Center

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Megan Brockel, MD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Months

Max Age

2 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-24

Primary Completion

2023-09-20

Completion

2023-09-20

FDA Drug

Yes

Countries

• United States

Study Locations