- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145415
Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair.
In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Nemours/ duPont Hospital for Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Boys undergoing hypospadias repair
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bilateral Pudendal block
0.25 cc per kg of 0.2% ropivacaine will be injected once for right pudendal N block and the same volume for the left pudendal N block before the start of the surgery
|
0.5 cc per kg of 0.2% ropivicaine.
Half of the volume given as a right pudendal block and the remaining volume given on the left pudendal nerve block given prior to the start of surgery
|
Active Comparator: Caudal block
1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
|
1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid consumption
Time Frame: up to 24 hours
|
The child's care giver will document the times that a rescue opioid was given to relieve pain.
|
up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative block assessment
Time Frame: up to 3 hours
|
A heart rate increase above of 20 percent of baseline will be an indication of inadequate block that will be treated with a rescue opioid.
|
up to 3 hours
|
Post operative pain
Time Frame: up to 2 hours
|
The FLACC scale scores greater than 6 will be an indication of inadequate pain relief needing a rescue dosages of opioid.
|
up to 2 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- lh0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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