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Trial record 50 of 117 for:    "Penile Disease"

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

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ClinicalTrials.gov Identifier: NCT02164682
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Hypospadias Procedure: IV PCA group Procedure: IV PCA+ caudal block group

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Study Type : Observational
Actual Enrollment : 404 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort Intervention/treatment
IV PCA group Procedure: IV PCA group
The IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen

IV PCA+ caudal block group 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.)




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164682


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02164682     History of Changes
Other Study ID Numbers: 4-2014-0294
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Yonsei University:
Hypospadias repair
Caudal block
Postoperative complications

Additional relevant MeSH terms:
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Postoperative Complications
Hypospadias
Pathologic Processes
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities