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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Nemours Children's Clinic

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Nemours Children's Clinic

Dates:
Date Received: May 3, 2017
Date Started: May 15, 2017
Date Completion: April 30, 2018
Last Updated: May 8, 2017
Last Verified: April 2017