Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
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|ClinicalTrials.gov Identifier: NCT03145415|
Recruitment Status : Unknown
Verified April 2017 by Nemours Children's Clinic.
Recruitment status was: Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypospadias and Epispadias||Procedure: Caudal block Procedure: Bilateral Pudendal block||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||No other parties will be masked.|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial|
|Estimated Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||April 30, 2018|
Experimental: 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
Procedure: 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
Active Comparator: Caudal block
1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
Procedure: Caudal block
1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
- 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.
- 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.