Pudendal Block Versus Caudal Block for Hypospadias

Overview

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.

Full Title of Study: “A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 2015

Detailed Description

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.

Interventions

  • Procedure: pudendal nerve block
    • nerve stimulator-guided Pudendal block
  • Procedure: caudal block
    • caudal block

Arms, Groups and Cohorts

  • Active Comparator: pudendal block group
    • nerve stimulated pudendal nerve block performed under general anesthesia
  • Active Comparator: Caudal block group
    • caudal block performed under general anesthesia

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • time to to first use of analgesic
    • Time Frame: 24 hours
  • parental satisfaction
    • Time Frame: 24 hours
    • Parent satisfaction was scored as: definitely unsatisfied; satisfied; definitely satisfied.
  • the incidence of side effects
    • Time Frame: 24 hours
  • 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)
  • postoperative total analgesic requirements
    • Time Frame: 24 hours

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 1 Year

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istanbul University
  • Collaborator
    • Ayse Cigdem Tutuncu
  • Provider of Information About this Clinical Study
    • Principal Investigator: pinar kendigelen, M.D.(Anesthesiology Specialist) – Istanbul University
  • Overall Official(s)
    • Guner Kaya, Prof., Study Director, Istanbul University

References

Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.

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