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

Hypospadias and Epispadias Clinical Trial

Official title:

Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145415
• Other study ID #: lh0001
• Status: Completed
• Phase: N/A
• Start date: February 17, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: April 2017
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Months to 2 Years

Eligibility

Inclusion Criteria:

• Boys undergoing hypospadias repair

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hypospadias
• Hypospadias and Epispadias

Intervention

Procedure:
• Caudal block
1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
• 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

Locations

Country	Name	City	State
United States	Nemours/ duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	The child's care giver will document the times that a rescue opioid was given to relieve pain.	up to 24 hours
Secondary	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.	up to 3 hours
Secondary	Post operative pain	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