Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
- Conditions
- Hypospadias and Epispadias
- Interventions
- Procedure: Bilateral Pudendal blockProcedure: 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
- Boys undergoing hypospadias repair
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bilateral Pudendal block Bilateral Pudendal block 0.25 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 block Caudal block 1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
- 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