NCT02345785

Brief Summary

The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal block using ultrasonography in pediatric patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

October 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2016

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

January 12, 2015

Last Update Submit

February 25, 2019

Conditions

Pediatric Urologic Surgeries

Outcome Measures

Primary Outcomes (3)

  • change of penile corpus cavernosum

    Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children

    1 min after LMA insertion

  • change of penile corpus cavernosum

    Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children

    2 min after caudal block

  • change of penile corpus cavernosum

    Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children

    5 min after caudal block

Secondary Outcomes (3)

  • cavernosal arterial hemodynamics

    1 min after LMA insertion

  • cavernosal arterial hemodynamics

    2 min after caudal block

  • cavernosal arterial hemodynamics

    5 min after caudal block

Study Arms (1)

Group 1

pediatric patients who need urologic surgery and caudal block

Other: urologic surgery and caudal block

Interventions

urologic surgery and caudal blockOTHER
Group 1

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pediatric patients who need urologic surgery and caudal block

You may qualify if:

  • Twenty (ASA status I or II) children, ages 2 to 7 yr old, who were scheduled for a urologic surgery
  • Children who needed caudal block for postoperative analgesia

You may not qualify if:

  • if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
  • patients scheduled for penile surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Urologic Surgical Procedures

Intervention Hierarchy (Ancestors)

Urogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 26, 2015

Study Start

October 2, 2015

Primary Completion

January 22, 2016

Study Completion

January 22, 2016

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

KR(1)