The Effect of Caudal Block on the Postoperative Complications in Pediatric Patients After Hypospadias Repair

Study Overview
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Brief Summary
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Hypospadias refers to a disease represented by a congenital defect in the urethra meatus (urinary opening) in male children. Due to the postoperative pain, symptoms such as discomfort, agitation, and restlessness are generally found. In particular, young children with restlessness often express their pain or discomfort with their bodies because they are unable to express it in words. This severe restlessness may make an operated region unstable, accompanying bleeding, infection, or other surgery-related complications. Because postoperative pain control is very important, neuraxial block techniques such as epidural block or caudal block have been employed in addition to a penile dorsal nerve block. Although the neuraxial block technique including the caudal block is an easy and safe method and has an excellent effect, the neuraxial block technique poses a potential risk in the procedure. In addition, with respect to the surgical prognosis, it has been reported that penile engorgement may cause penile vasodilation, resulting in oozing at the surgical region or other surgical complications. However, there has not been a report on the increase of postoperative complications by penile vasodilation or on the difference in the recovery or surgical prognosis according to the types of pain control for young patients.

Conditions
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Hypospadias

Intervention / Treatment
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* Procedure: IV PCA group
* Procedure: IV PCA+ caudal block group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients who underwent the tubularized incised plate (TIP) repair under hypospadias at our institution between January, 2010 and December, 2014 Exclusion Criteria: Patients whose medical records could not be analyzed for having undergone the first hypospadias surgery at another institution. Other exclusion criteria were as follows: over the age of 8 years, planned two-stage hypospadias repair, receiving continuous epidural analgesia, and without hypospadias as the final diagnosis.

Ages Eligible for Study
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Maximum Age: 7 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IV PCA group<br> | Procedure: IV PCA group<br>* The IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen<br>|
| IV PCA+ caudal block group<br> | Procedure: IV PCA+ caudal block group<br>* The IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen + caudal block was 0.15% ropivacaine 1.2 cc/kg; a total volume of 100 cc, basal 2 cc, bolus 0.5 cc, and lockout time 15 minutes.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative complications related hypospadias repair | The electronic medical records of pediatric patients who underwent hypospadias repair will be reviewed to analyze the difference in postoperative complications within 6 months after surgery between patients whose postoperative pain control was performed only by IV PCA and patients whose postoperative pain control was performed by caudal block combined with IV PCA. | within 6 months after hypospadias repair | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypospadias repair, Caudal block, Postoperative complications