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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Detailed Description

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.

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

Arms, Groups and Cohorts

  • Active Comparator: Caudal block
    • Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.
  • Active Comparator: Penile Nerve Block
    • Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of urethrocutaneous fistula
    • Time Frame: 1 year
    • Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.

Secondary Measures

  • 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.
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 4 Months

Maximum Age: 2 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Collaborator
    • Stanford University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Megan Brockel, MD, Principal Investigator, University of Colorado, Denver

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