Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children

Study Overview
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Brief Summary
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The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.

Detailed Description
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Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair. In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.

Official Title
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Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial

Conditions
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Hypospadias and Epispadias

Intervention / Treatment
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* Procedure: Caudal block
* Procedure: Bilateral Pudendal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Boys undergoing hypospadias repair Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral Pudendal block<br>0.25 cc per kg of 0.2% ropivacaine will be injected once for right pudendal N block and the same volume for the left pudendal N block before the start of the surgery | Procedure: Bilateral Pudendal block<br>* 0.5 cc per kg of 0.2% ropivicaine. Half of the volume given as a right pudendal block and the remaining volume given on the left pudendal nerve block given prior to the start of surgery<br>|
| Active Comparator: Caudal block<br>1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery | Procedure: Caudal block<br>* 1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | The child's care giver will document the times that a rescue opioid was given to relieve pain. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative block assessment | A heart rate increase above of 20 percent of baseline will be an indication of inadequate block that will be treated with a rescue opioid. | up to 3 hours | 
| Post operative pain | The FLACC scale scores greater than 6 will be an indication of inadequate pain relief needing a rescue dosages of opioid. | up to 2 hours | 

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