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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02164682
Enrollment
404
Registered
2014-06-16
Start date
2014-06-30
Completion date
2015-01-31
Last updated
2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Keywords

Hypospadias repair, Caudal block, Postoperative complications

Brief 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.

Interventions

PROCEDUREIV PCA group

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

PROCEDUREIV PCA+ caudal block group

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.)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
No minimum to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The postoperative complications related hypospadias repairwithin 6 months after hypospadias repairThe 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026