Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children

Not Applicable

Completed

• Conditions: Hypospadias and Epispadias

• Registration Number: NCT03145415
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study Start: 2017-02-17
• Status Verified: 2017-04
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-09
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Boys undergoing hypospadias repair

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opioid consumption	up to 24 hours	The child's care giver will document the times that a rescue opioid was given to relieve pain.

Secondary Outcome Measures

Name	Time	Method
Post operative pain	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.
Intraoperative block assessment	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.

Trial Locations

Locations (1)

Nemours/ duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States