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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: Male
• Age: 6 Months – 2 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypospadias and Epispadias

Interventions

Type	Name	Description
PROCEDURE	Caudal block	1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
PROCEDURE	Bilateral Pudendal block	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

Timeline

• Start date: 2017-02-17
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2017-05-09
• Last updated: 2022-05-19

Locations

1 site across 1 country: United States