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Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair

Primary Purpose

Postoperative Pain, Hypospadias

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Dr Sonia ben khalifa (PhD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Intravenous Dexamethasone, Pudendal nerve block, Analgesia, Postoperative pain, Children, Hypospadias

Eligibility Criteria

1 Year - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status classification 1 or 2
  • Procedure: hypospadias repair
  • Eligible for a pudendal nerve block

Exclusion Criteria:

  • parents or patient refusal
  • nerve block failure
  • Peroperative complication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Dexamethasone group

    Placebo group

    Arm Description

    Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline

    Patients who received the same volume of saline as the study group (8ml)

    Outcomes

    Primary Outcome Measures

    The mean time to first rescue analgesic
    Time from the end of surgery to the first administration of rescue analgesic
    number of rescue analgesic consumption
    Total number of rescue analgesic consumption for each patient

    Secondary Outcome Measures

    pain scores (CHEOPS)
    CHEOPS score ranges from 4 to 13. 13 is the worst score. If the score was superior to 7 rescue analgesia was administrated.
    Number of episodes of postoperative nausea and vomiting
    Number of episodes of postoperative nausea and vomiting in each patient

    Full Information

    First Posted
    April 1, 2019
    Last Updated
    April 2, 2019
    Sponsor
    Dr Sonia ben khalifa (PhD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03902249
    Brief Title
    Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair
    Official Title
    Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Sonia ben khalifa (PhD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.
    Detailed Description
    It was a prospective study, randomized, double blind study, conducted at the Tunis Children's Hospital (January 2017-December 2018). After agreement with parents and the local ethics committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a hypospadias repair. Patients were randomized to: Group D receiving 0. 15mg/kg of Dexamethasone IV after induction and group P receiving the same volume of saline. The pudendal block was performed by neurostimulation after induction with Sevoflurane and 3 gamma/kg Fentanyl IV. The success of the block was tested at 10 and 15 minutes, it was declared successful when the systolic blood pressure and heart rate did not increase by more than 20% compared to the baseline values at the time of the incision. No analgesics were administered at the end of the surgery. The pain was assessed by the CHEOPS score the first 24 hours. The X2 test was used for qualitative variables and the student test for quantitative variables with P<0. 05 as the significance threshold. The number of patients required for the study was calculated (alpha=5% beta=90%) and was 62.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Hypospadias
    Keywords
    Intravenous Dexamethasone, Pudendal nerve block, Analgesia, Postoperative pain, Children, Hypospadias

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone group
    Arm Type
    Active Comparator
    Arm Description
    Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients who received the same volume of saline as the study group (8ml)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Primary Outcome Measure Information:
    Title
    The mean time to first rescue analgesic
    Description
    Time from the end of surgery to the first administration of rescue analgesic
    Time Frame
    The first 24 hours after surgery
    Title
    number of rescue analgesic consumption
    Description
    Total number of rescue analgesic consumption for each patient
    Time Frame
    The first 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    pain scores (CHEOPS)
    Description
    CHEOPS score ranges from 4 to 13. 13 is the worst score. If the score was superior to 7 rescue analgesia was administrated.
    Time Frame
    Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24
    Title
    Number of episodes of postoperative nausea and vomiting
    Description
    Number of episodes of postoperative nausea and vomiting in each patient
    Time Frame
    The first 24 hours after surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA physical status classification 1 or 2 Procedure: hypospadias repair Eligible for a pudendal nerve block Exclusion Criteria: parents or patient refusal nerve block failure Peroperative complication.

    12. IPD Sharing Statement

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