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Completed

NCT Number: NCT02164682

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV PCA group

Procedure

The IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen

IV PCA+ caudal block group

Procedure

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.)

Primary outcomes

  1. The postoperative complications related hypospadias repair

    Time frame: within 6 months after 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2014
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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