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

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Nemours Children's Health

Status

Completed

Conditions

Hypospadias and Epispadias

Treatments

Procedure: Bilateral Pudendal block
Procedure: Caudal block

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Male

Ages

6 months to 2 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Boys undergoing hypospadias repair

Exclusion criteria

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Bilateral Pudendal block
Experimental group
Description:
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
Treatment:
Procedure: Bilateral Pudendal block
Caudal block
Active Comparator group
Description:
1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
Treatment:
Procedure: Caudal block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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