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

Not Applicable
Completed
Conditions
Hypospadias and Epispadias
Interventions
Procedure: Bilateral Pudendal block
Procedure: Caudal block
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
60
Inclusion Criteria
  • Boys undergoing hypospadias repair
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Exclusion Criteria
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Bilateral Pudendal blockBilateral Pudendal block0.25 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
Caudal blockCaudal block1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
Primary Outcome Measures
NameTimeMethod
Opioid consumptionup to 24 hours

The child's care giver will document the times that a rescue opioid was given to relieve pain.

Secondary Outcome Measures
NameTimeMethod
Post operative painup 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 assessmentup 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

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