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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

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE May 9, 2017
Last Update Posted Date May 9, 2017
Estimated Study Start Date  ICMJE May 15, 2017
Estimated Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children
Official Title  ICMJE Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Hypospadias and Epispadias
Intervention  ICMJE
  • Procedure: Caudal block
    1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Bilateral Pudendal block
  • Active Comparator: Caudal block
    1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
    Intervention: Procedure: Caudal block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2018
Estimated Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Boys undergoing hypospadias repair

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 6 Months to 2 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03145415
Other Study ID Numbers  ICMJE lh0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nemours Children's Clinic
Study Sponsor  ICMJE Nemours Children's Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nemours Children's Clinic
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP