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Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair

Primary Purpose

Hypospadias

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupivacaine
General anesthesia
Dilute epinephrine injection
Fentanyl
dextrose plus sodium chloride.
neostigmine and atropine
Hypospadias repair
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypospadias

Eligibility Criteria

6 Months - 15 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

age between 6 months to 15 years and hypospadias with any severity

Exclusion Criteria:

coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    General anesthesia + caudal block

    General anesthesia only

    Arm Description

    Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation

    Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation

    Outcomes

    Primary Outcome Measures

    Intraoperative blood loss
    The amount of blood loss during the operation

    Secondary Outcome Measures

    Dose of fentanyl used
    operation time

    Full Information

    First Posted
    April 20, 2016
    Last Updated
    April 25, 2016
    Sponsor
    Isfahan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02752308
    Brief Title
    Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair
    Official Title
    Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair; A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isfahan University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    From September 2014 to March 2015, 57 consecutive patients with hypospadias who are candidate for surgery will be enrolled in this randomized clinical trial. Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of the study and all parents will sign a written informed consent. Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity. Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated. All selected patients will randomly allocate to one of the two groups: group A will receive caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive general anesthesia before surgery and CEB afterwards. The surgical procedures will be performed by a single pediatric urologist (FA). The surgical technique will be tubularized incised plate in all cases. Intraoperative blood loss will be determined by weighing all surgical gauzes used during procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to minimize the effect of water vaporization on gauzes weights. In addition to blood loss, operation time, dose of fentanyl used during procedure and length of the urethral plate defect will be recorded for each patient by trained nurses. Demographics and disease characteristics as well as operation details will be compared in the two studied groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypospadias

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    General anesthesia + caudal block
    Arm Type
    Active Comparator
    Arm Description
    Patients who receive general anesthesia plus caudal epidural block and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation
    Arm Title
    General anesthesia only
    Arm Type
    Active Comparator
    Arm Description
    Patients who receive only general anesthesia and dilute epinephrine injection before hypospadias repair, intraoperative fentanyl, intraoperative intravenous fluid and reversing the muscle relaxants' effect at the end of operation
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Caudal block
    Intervention Description
    Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg)
    Intervention Type
    Procedure
    Intervention Name(s)
    General anesthesia
    Intervention Description
    Induction with thiopental sodium 5 mg/Kg, atracurium 0.4 mg/Kg and fentanyl 2 mcg/Kg and maintenance with isoflurane and a combination of oxygen and nitrous oxide
    Intervention Type
    Drug
    Intervention Name(s)
    Dilute epinephrine injection
    Intervention Description
    Injection of 1/100000 epinephrine solution along all incision lines
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline
    Intervention Type
    Drug
    Intervention Name(s)
    dextrose plus sodium chloride.
    Intervention Description
    Four mL/Kg/hr of 5% dextrose plus 0.04 mL/Kg/hr of 20% sodium chloride. Each mL of blood loss was replaced by 3 ml of Ringer's solution
    Intervention Type
    Drug
    Intervention Name(s)
    neostigmine and atropine
    Intervention Description
    Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hypospadias repair
    Intervention Description
    Surgical repair of hypospadias, using tubularized incised plate technique
    Primary Outcome Measure Information:
    Title
    Intraoperative blood loss
    Description
    The amount of blood loss during the operation
    Time Frame
    During procedure
    Secondary Outcome Measure Information:
    Title
    Dose of fentanyl used
    Time Frame
    during the operation
    Title
    operation time
    Time Frame
    during procedure

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age between 6 months to 15 years and hypospadias with any severity Exclusion Criteria: coagulopathy, history of previous failed surgery, skin infection , parents' disagreement with the protocol and any cardiac problem that made epinephrine injection contraindicated

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair

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