Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?
NCT ID: NCT02861950
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
165 participants
INTERVENTIONAL
2017-05-24
2023-09-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Caudal block
Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.
Caudal block with ropivacaine
Patients in this arm will receive a caudal block with ropivacaine
Penile Nerve Block
Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.
penile nerve block with bupivacaine
Patients in this arm will receive a penile block with bupivacaine
Interventions
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Caudal block with ropivacaine
Patients in this arm will receive a caudal block with ropivacaine
penile nerve block with bupivacaine
Patients in this arm will receive a penile block with bupivacaine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* proximal or penoscrotal hypospadias,
* abnormal caudal anatomy or spinal dysraphism,
* cyanotic congenital heart disease,
* infection or rash at the block injection site.
4 Months
2 Years
MALE
No
Sponsors
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Stanford University
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Boston Children's Hospital
OTHER
Children's Medical Center of Dallas/UT Southwestern
UNKNOWN
University of Mississippi Medical Center
OTHER
University of New Mexico
OTHER
University of Michigan
OTHER
Children's National Research Institute
OTHER
University of Wisconsin, Madison
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Megan Brockel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Other Identifiers
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15-2343
Identifier Type: -
Identifier Source: org_study_id
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