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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypospadias, Urethrocutaneous Fistula

Intervention / Treatment
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* Drug: Caudal block with ropivacaine
* Drug: penile nerve block with bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal block<br>Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine. | Drug: Caudal block with ropivacaine<br>* Patients in this arm will receive a caudal block with ropivacaine<br>|
| Active Comparator: Penile Nerve Block<br>Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine. | Drug: penile nerve block with bupivacaine<br>* Patients in this arm will receive a penile block with bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of urethrocutaneous fistula | Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of efficacy of caudal block | Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed. | 1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery | 
| Degree of pain | Patients will have pain scores determined using the modified FLACC score (Face, Legs, Activity, Cry, Consolability) 1 hour after arrival in the PACU | 1 hour after arrival in PACU post surgery | 
| Need for supplemental analgesics | Administration of opioid in the first postoperative hour will be determined | 1 hour after arrival in PACU post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypospadias, caudal, urethrocutaneous fistula, penile nerve block