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Completed

NCT Number: NCT03145415

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

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.

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Key information

Conditions

Hypospadias and Epispadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epispadias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Penile Diseases Urethral Diseases Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

6 month–2 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nemours/ duPont Hospital for Children

Wilmington, Delaware, 19803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Boys undergoing hypospadias repair

Exclusion criteria

-

Treatment and study plan

Caudal block

Procedure

1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.

Bilateral Pudendal block

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 9, 2017
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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