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NCT Number: NCT02390388

Pudendal Block Versus Caudal Block for Hypospadias

The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.

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Key information

Conditions

Pain Agnosia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Penile Diseases Perceptual Disorders Signs and Symptoms Urogenital Abnormalities Urogenital Diseases

Age range

1 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

About this study

In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status I-II
  • aged 1 to 10 years scheduled undergoing hypospadias surgery

Exclusion criteria

  • history of allergic reactions to local anesthetics
  • rash or infection at the injection site
  • anatomical abnormality
  • bleeding diatheses, coagulopathy, liver diseases

Treatment and study plan

Pudendal nerve block

Procedure

nerve stimulator-guided Pudendal block

Caudal block

Procedure

caudal block

Primary outcomes

  1. postoperative pain intensity measure

    Time frame: 24 hours

    pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate.

Secondary outcomes

  1. time to to first use of analgesic

    Time frame: 24 hours

  2. parental satisfaction

    Time frame: 24 hours

    Parent satisfaction was scored as:

    • definitely unsatisfied;
    • satisfied;
    • definitely satisfied.

  3. the incidence of side effects

    Time frame: 24 hours

  4. intraoperative analgesic requirement

    Time frame: intraoperative

    intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion)

  5. postoperative total analgesic requirements

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Ayse Cigdem Tutuncu
  • Fatis Altindas
  • Kaya, Guner, M.D.
  • Senol Emre

Registry information

Official study title

A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2015
Registry last updated
Aug 26, 2015

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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