Back to resultsComparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
Primary Purpose
Hypospadias and Epispadias
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caudal block
Bilateral Pudendal block
Sponsored by
About this trial
This is an interventional supportive care trial for Hypospadias and Epispadias focused on measuring pudendal nerve block, hypospadias, caudal block
Eligibility Criteria
Inclusion Criteria:
- Boys undergoing hypospadias repair
Exclusion Criteria:
-
Sites / Locations
- Nemours/ duPont Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bilateral Pudendal block
Caudal block
Arm Description
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
1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
Outcomes
Primary Outcome Measures
Opioid consumption
The child's care giver will document the times that a rescue opioid was given to relieve pain.
Secondary Outcome Measures
Intraoperative block assessment
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.
Post operative pain
The FLACC scale scores greater than 6 will be an indication of inadequate pain relief needing a rescue dosages of opioid.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03145415
Brief Title
Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
Official Title
Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias and Epispadias
Keywords
pudendal nerve block, hypospadias, caudal block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
No other parties will be masked.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral Pudendal block
Arm Type
Experimental
Arm Description
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
Arm Title
Caudal block
Arm Type
Active Comparator
Arm Description
1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
Intervention Type
Procedure
Intervention Name(s)
Caudal block
Intervention Description
1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Pudendal block
Intervention Description
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
Primary Outcome Measure Information:
Title
Opioid consumption
Description
The child's care giver will document the times that a rescue opioid was given to relieve pain.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Intraoperative block assessment
Description
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.
Time Frame
up to 3 hours
Title
Post operative pain
Description
The FLACC scale scores greater than 6 will be an indication of inadequate pain relief needing a rescue dosages of opioid.
Time Frame
up to 2 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Boys undergoing hypospadias repair
Exclusion Criteria:
-
Facility Information:
Facility Name
Nemours/ duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36283712
Citation
Choudhry DK, Heredia L, Brenn BR, Brown M, Carvalho NF, Whaley MC, Shaik SS, Hagerty JA, Bani Hani A. Nerve stimulation guided bilateral pudendal nerve block versus landmark-based caudal block for hypospadias repair in young children: a prospective, randomized, pragmatic trial. Reg Anesth Pain Med. 2022 Dec;47(12):744-748. doi: 10.1136/rapm-2022-103680. Epub 2022 Sep 8.
Results Reference
derived
Learn more about this trial
Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
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