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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 : 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
Sponsor:
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.



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

Inclusion Criteria:

  • Boys undergoing hypospadias repair

Exclusion Criteria:

-


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Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03145415     History of Changes
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
hypospadias
caudal block
Additional relevant MeSH terms:
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Hypospadias
Epispadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Urethral Diseases
Urologic Diseases