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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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)
Estimated 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
Estimated Study Start Date : May 15, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

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:


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Responsible Party: Nemours Children's Clinic Identifier: NCT03145415    
Other Study ID Numbers: lh0001
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
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