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

NCT ID: NCT02164682

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

404 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-01-31

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.

Detailed Description

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Conditions

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Hypospadias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IV PCA group

IV PCA group

Intervention Type PROCEDURE

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

IV PCA+ caudal block group

IV PCA+ caudal block group

Intervention Type 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.)

Interventions

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IV PCA group

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

Intervention Type PROCEDURE

IV 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.)

Intervention Type PROCEDURE

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
Maximum Eligible Age

7 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0294

Identifier Type: -

Identifier Source: org_study_id

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