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Completed

NCT Number: NCT02345785

Evaluation of the Change of Penile Corpus Cavernosum After Caudal Block Using Ultrasonography in Children

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

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Key information

Conditions

Pediatric Urologic Surgeries

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

urologic surgery and caudal block

Other

Primary outcomes

  1. change of penile corpus cavernosum

    Time frame: 1 min after LMA insertion

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

  2. change of penile corpus cavernosum

    Time frame: 2 min after caudal block

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

  3. change of penile corpus cavernosum

    Time frame: 5 min after caudal block

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

Secondary outcomes

  1. cavernosal arterial hemodynamics

    Time frame: 1 min after LMA insertion

    Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].

  2. cavernosal arterial hemodynamics

    Time frame: 2 min after caudal block

    Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].

  3. cavernosal arterial hemodynamics

    Time frame: 5 min after caudal block

    Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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