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

NCT02861950 | Completed Phase 4 FDA Drug

• 1 other identifier: 15-2343
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hypospadias; caudal; urethrocutaneous fistula; penile nerve block

Outcome Measures

Primary Outcomes (1)

• Incidence of urethrocutaneous fistula

  Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.

  1 year

Secondary Outcomes (3)

• Degree of efficacy of caudal block

  1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery

• Degree of pain

  1 hour after arrival in PACU post surgery

• Need for supplemental analgesics

  1 hour after arrival in PACU post surgery

Study Arms (2)

Caudal block

ACTIVE COMPARATOR

Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.

Drug: Caudal block with ropivacaine

Penile Nerve Block

ACTIVE COMPARATOR

Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.

Drug: penile nerve block with bupivacaine

Interventions

Caudal block with ropivacaine DRUG

Patients in this arm will receive a caudal block with ropivacaine

Caudal block

penile nerve block with bupivacaine DRUG

Patients in this arm will receive a penile block with bupivacaine

Penile Nerve Block

Eligibility Criteria

• Age: 4 Months - 2 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.

You may not qualify if:

• prior hypospadias surgery,
• proximal or penoscrotal hypospadias,
• abnormal caudal anatomy or spinal dysraphism,
• cyanotic congenital heart disease,
• infection or rash at the block injection site.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Stanford University: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Boston Children's Hospital: collaborator
• Children's Medical Center of Dallas/UT Southwestern: collaborator
• University of Mississippi Medical Center: collaborator
• University of New Mexico: collaborator
• University of Michigan: collaborator
• Children's National Research Institute: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hypospadias

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Megan Brockel, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: August 10, 2016
• Study Start: May 24, 2017
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)