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Pudendal Block Versus Caudal Block for Hypospadias

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pudendal nerve block
caudal block
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pudendal block, Hypospadias, caudal block, child, analgesia

Eligibility Criteria

1 Year - 10 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    pudendal block group

    Caudal block group

    Arm Description

    nerve stimulated pudendal nerve block performed under general anesthesia

    caudal block performed under general anesthesia

    Outcomes

    Primary Outcome Measures

    postoperative pain intensity measure
    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 Outcome Measures

    time to to first use of analgesic
    parental satisfaction
    Parent satisfaction was scored as: definitely unsatisfied; satisfied; definitely satisfied.
    the incidence of side effects
    intraoperative analgesic requirement
    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

    Full Information

    First Posted
    January 26, 2015
    Last Updated
    August 25, 2015
    Sponsor
    Istanbul University
    Collaborators
    Ayse Cigdem Tutuncu, Senol Emre, Fatis Altindas, Kaya, Guner, M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02390388
    Brief Title
    Pudendal Block Versus Caudal Block for Hypospadias
    Official Title
    A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University
    Collaborators
    Ayse Cigdem Tutuncu, Senol Emre, Fatis Altindas, Kaya, Guner, M.D.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain
    Keywords
    pudendal block, Hypospadias, caudal block, child, analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pudendal block group
    Arm Type
    Active Comparator
    Arm Description
    nerve stimulated pudendal nerve block performed under general anesthesia
    Arm Title
    Caudal block group
    Arm Type
    Active Comparator
    Arm Description
    caudal block performed under general anesthesia
    Intervention Type
    Procedure
    Intervention Name(s)
    pudendal nerve block
    Intervention Description
    nerve stimulator-guided Pudendal block
    Intervention Type
    Procedure
    Intervention Name(s)
    caudal block
    Intervention Description
    caudal block
    Primary Outcome Measure Information:
    Title
    postoperative pain intensity measure
    Description
    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.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    time to to first use of analgesic
    Time Frame
    24 hours
    Title
    parental satisfaction
    Description
    Parent satisfaction was scored as: definitely unsatisfied; satisfied; definitely satisfied.
    Time Frame
    24 hours
    Title
    the incidence of side effects
    Time Frame
    24 hours
    Title
    intraoperative analgesic requirement
    Description
    intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion)
    Time Frame
    intraoperative
    Title
    postoperative total analgesic requirements
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guner Kaya, Prof.
    Organizational Affiliation
    Istanbul University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24257391
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27501015
    Citation
    Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
    Results Reference
    derived

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    Pudendal Block Versus Caudal Block for Hypospadias

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