- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02164682
The Effect of Caudal Block on the Postoperative Complications in Pediatric Patients After Hypospadias Repair
August 25, 2015 updated by: Yonsei University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
404
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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).
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IV PCA group
|
The IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen
|
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.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 6 months after hypospadias repair
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
June 12, 2014
First Submitted That Met QC Criteria
June 12, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Estimate)
August 26, 2015
Last Update Submitted That Met QC Criteria
August 25, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2014-0294
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypospadias
-
Albany Medical CollegeEnrolling by invitation
-
Sohag UniversityCompletedCosmotic Outcome of Distal Penile Hypospidias Repair Using Stitch by Stitch Glanuloplasty Versus TIPDistal Penile HypospadiasEgypt
-
Assiut UniversityNot yet recruiting
-
Yonsei UniversityCompletedPediatric Patients Undergoing Hypospadias SurgeryKorea, Republic of
-
dr. Muhammad Abdelhafez Mahmoud, MDCompletedChordee | Hypospadias, Penoscrotal
-
Tanta UniversityUnknownPediatric | Dexmedetomidine Infusion | Hypospadias Repair SurgeryEgypt
-
Isfahan University of Medical SciencesUnknown
-
Nemours Children's ClinicCompletedHypospadias and EpispadiasUnited States
-
Mansoura UniversityCompleted164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal BlockEgypt
Clinical Trials on IV PCA group
-
Taichung Veterans General HospitalUnknownPain, PostoperativeTaiwan
-
Seoul National University HospitalCompletedAnalgesia, Patient-ControlledKorea, Republic of
-
Chengdu University of Traditional Chinese MedicineNot yet recruitingPostoperative Pain After Hemorrhoidectomy
-
University Health Network, TorontoCompletedPostoperative Pain | Liver ResectionCanada
-
Nang Kuang Pharmaceutical Co., Ltd.Suspended
-
Kaohsiung Medical University Chung-Ho Memorial...Unknown
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingPain Management | Liver CancerUnited States
-
Seoul National University Bundang HospitalNot yet recruitingBrachial Plexus Block | Analgesia, Patient-Controlled | Arthroscopic Rotator Cuff Repair
-
China Medical University HospitalUnknownPostoperative PainTaiwan
-
Fujian Cancer HospitalCompleted