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Trial record 7 of 29 for:    Recruiting, Not yet recruiting, Available Studies | "Penile Diseases"

Effect of Caudal and Penile Block on Hypospadias Repair Complications

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ClinicalTrials.gov Identifier: NCT02851290
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Nicolette Janzen, Baylor College of Medicine

Brief Summary:
Hypospadias is one of the most common genitourinary (GU) malformations, seen in approximately 1 of 250 male live births. Common methods of local anesthesia administration for hypospadias surgery include caudal and dorsal penile nerve blocks. While both methods are known to be effective with minimal risk, the effect on post-operative complications is not well-established. The purpose of this randomized controlled trial is to evaluate if caudal versus dorsal penile nerve block results in higher rates of post-operative complications.

Condition or disease Intervention/treatment Phase
Hypospadias Procedure: Caudal block anesthesia Procedure: Dorsal penile nerve block anesthesia Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Caudal and Penile Block on Hypospadias Repair Complications
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: Caudal block
Local anesthetic will be administered into the caudal space
Procedure: Caudal block anesthesia
After induction of general anesthesia, a caudal block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine

Active Comparator: Dorsal penile nerve block
Local anesthetic will be administered around the dorsal penile nerve
Procedure: Dorsal penile nerve block anesthesia
After induction of general anesthesia, a dorsal penile nerve block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine




Primary Outcome Measures :
  1. Post-operative hypospadias repair complications [ Time Frame: 24 months post-operatively ]
    Post-operative follow-up to evaluate for post-operative complications including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and urethral stricture


Secondary Outcome Measures :
  1. Post-operative hypospadias repair pain [ Time Frame: 1 hour post-operatively ]
    Post-operative pain will be assessed using the FLACC scale (faces, legs, activity, cry and consolability scale)

  2. Caudal block-related complications [ Time Frame: 1 hour post-operatively ]
    Complications related to caudal block

  3. Dorsal penile nerve block-related complications [ Time Frame: 1 hour post-operatively ]
    Complications related to dorsal penile nerve block



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Ages Eligible for Study:   4 Months to 4 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 4 months to 4 years
  • ASA score I and II
  • Primary hypospadias repair in one stage including distal, midshaft, and proximal repairs

Exclusion criteria:

  • Age <4 months or >4 years
  • ASA score >II
  • Genetic syndromes
  • Previous hypospadias operations
  • Staged hypospadias repair operations
  • Spinal dysraphism or other contraindications to caudal block
  • Infection at the block site
  • Refusal of consent by the parents
  • Unwillingness of the anesthesiologist or surgeon to participate

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): NCT02851290


Contacts
Contact: Kara Toman 832-822-3310 kara.toman@bcm.edu
Contact: Carolyn Galvan 832-822-3160 cjgalvan@texaschildrens.org

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Kara Toman    832-822-3310    kara.toman@bcm.edu   
Principal Investigator: Nicolette K Janzen, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Nicolette K Janzen, MD Texas Children's Hospital/Baylor College of Medicine

Responsible Party: Nicolette Janzen, Assistant Professor Pediatric Urology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02851290     History of Changes
Other Study ID Numbers: H-38540
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nicolette Janzen, Baylor College of Medicine:
Hypospadias
Caudal block
Dorsal penile nerve block
Anesthesia
Urethrocutaneous fistula
Urethral stricture
Meatal stenosis
Glanular dehiscence

Additional relevant MeSH terms:
Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs