Clinical Trials Directory

Trials / Completed

CompletedNCT02164682

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

Status
Completed
Phase
Study type
Observational
Enrollment
404 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
Male
Age
7 Years
Healthy volunteers
Accepted

Summary

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

Interventions

TypeNameDescription
PROCEDUREIV PCA groupThe IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen
PROCEDUREIV PCA+ caudal block groupThe 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.)

Timeline

Start date
2014-06-01
Primary completion
2015-01-01
Completion
2015-01-01
First posted
2014-06-16
Last updated
2015-08-26

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02164682. Inclusion in this directory is not an endorsement.