Hypospadias and Epispadias
Conditions
Keywords
pudendal nerve block, hypospadias, caudal block
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.
Interventions
PROCEDURECaudal block
1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
PROCEDUREBilateral 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
Sponsors
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
No other parties will be masked.
Intervention model description
All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.
Eligibility
Sex/Gender
MALE
Age
6 Months to 2 Years
Healthy volunteers
Yes
Inclusion criteria
* Boys undergoing hypospadias repair
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed