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

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ClinicalTrials.gov Identifier: NCT03145415
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : May 19, 2022
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypospadias and Epispadias Procedure: Caudal block Procedure: Bilateral Pudendal block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 2 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Boys undergoing hypospadias repair

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145415

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United States, Delaware
Nemours/ duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Sponsors and Collaborators
Nemours Children's Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03145415    
Other Study ID Numbers: lh0001
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nemours Children's Clinic:
pudendal nerve block
caudal block
Additional relevant MeSH terms:
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Penile Diseases
Urogenital Abnormalities
Congenital Abnormalities
Urethral Diseases
Urologic Diseases