NCT02851290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

6.9 years

First QC Date

July 28, 2016

Last Update Submit

May 19, 2023

Conditions

Hypospadias

Keywords

HypospadiasCaudal blockDorsal penile nerve blockAnesthesiaUrethrocutaneous fistulaUrethral strictureMeatal stenosisGlanular dehiscence

Outcome Measures

Primary Outcomes (1)

  • Post-operative hypospadias repair complications

    Post-operative follow-up to evaluate for post-operative complications including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and urethral stricture

    24 months post-operatively

Secondary Outcomes (3)

  • Post-operative hypospadias repair pain

    1 hour post-operatively

  • Caudal block-related complications

    1 hour post-operatively

  • Dorsal penile nerve block-related complications

    1 hour post-operatively

Study Arms (2)

Caudal block

EXPERIMENTAL

Local anesthetic will be administered into the caudal space

Procedure: Caudal block anesthesia

Dorsal penile nerve block

ACTIVE COMPARATOR

Local anesthetic will be administered around the dorsal penile nerve

Procedure: Dorsal penile nerve block anesthesia

Interventions

Caudal block anesthesiaPROCEDURE

After induction of general anesthesia, a caudal block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine

Caudal block
Dorsal penile nerve block anesthesiaPROCEDURE

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

Dorsal penile nerve block

Eligibility Criteria

Age4 Months - 4 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

HypospadiasUrethral Stricture

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrethral ObstructionUrethral DiseasesUrologic Diseases

Study Officials

  • Nicolette K Janzen, MD

    Texas Children's Hospital/Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Kara Toman, MPH

    Texas Children's Hospital/Baylor College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Pediatric Urology

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

July 1, 2016

Primary Completion

May 19, 2023

Study Completion

May 19, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)