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

NCT02164682 | Completed

• 1 other identifier: 4-2014-0294
• Study Type: observational
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypospadias

Keywords

Hypospadias repair; Caudal block; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

IV PCA group

Procedure: IV PCA group

IV PCA+ caudal block group

Procedure: IV PCA+ caudal block group

Interventions

IV PCA group PROCEDURE

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

IV PCA group

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.)

IV PCA+ caudal block group

Eligibility Criteria

• Age: Up to 7 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients who underwent the first hypospadias surgery at our institution between January, 2010 and December, 2014 (for 5 years).

You may qualify if:

• Pediatric patients who underwent the tubularized incised plate (TIP) repair under hypospadias at our institution between January, 2010 and December, 2014

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Hypospadias; Postoperative Complications

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

KR (1)