Clinical trial NCT02861950: Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?
Official title: Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypospadias
Urethrocutaneous Fistula
Keywords: hypospadias
caudal
urethrocutaneous fistula
penile nerve block
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Dartmouth-Hitchcock Medical Center
name: Boston Children's Hospital
name: Children's Medical Center of Dallas/UT Southwestern
name: University of Mississippi Medical Center
name: University of New Mexico
name: University of Michigan
name: Children's National Health System
name: University of Wisconsin, Madison
First posted: 2016-08-10
Enrollment: 165
Sex: MALE
Minimum age (years): 4
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of urethrocutaneous fistula
timeFrame: 1 year
Secondary outcomes:
measure: Degree of efficacy of caudal block
timeFrame: 1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery
measure: Degree of pain
timeFrame: 1 hour after arrival in PACU post surgery
measure: Need for supplemental analgesics
timeFrame: 1 hour after arrival in PACU post surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Megan Brockel, MD
role: PRINCIPAL_INVESTIGATOR
References: