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NCT Number: NCT02861950

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

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.

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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urethrocutaneous Fistula Urogenital Abnormalities Urogenital Diseases

Age range

4 month–2 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis:

There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block.

The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Caudal block with ropivacaine

Drug

Patients in this arm will receive a caudal block with ropivacaine

penile nerve block with bupivacaine

Drug

Patients in this arm will receive a penile block with bupivacaine

Primary outcomes

  1. Incidence of urethrocutaneous fistula

    Time frame: 1 year

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

Secondary outcomes

  1. Degree of efficacy of caudal block

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

    Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed.

  2. Degree of pain

    Time frame: 1 hour after arrival in PACU post surgery

    Patients will have pain scores determined using the modified FLACC score (Face, Legs, Activity, Cry, Consolability) 1 hour after arrival in the PACU

  3. Need for supplemental analgesics

    Time frame: 1 hour after arrival in PACU post surgery

    Administration of opioid in the first postoperative hour will be determined

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2016
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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