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Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial

Primary Purpose

Pediatric Cardiac Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bilateral erector spinae plane block in pediatric cardiac surgeries
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Cardiac Surgery

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I and II
  • Undergoing cardiac surgical procedures through a midline sternotomyPreoperative ejection fraction <35%

Exclusion Criteria:

  • Low-cardiac-output syndrome
  • Ventricular arrhythmia
  • Preoperative inotropic support
  • Known allergies to any of the study drugs
  • Intubation for more than 3 hours or re-exploration
  • A redo or emergency surgery
  • Contraindications to regional anesthesia as coagulopathy and infection in site of block.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    group A

    Group B

    Group C

    Arm Description

    bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side

    bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) + dexamethasone 0.1 mg/kg for each side

    control group will receive the standard analgesic regimen only

    Outcomes

    Primary Outcome Measures

    postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
    The primary outcome of this study is the intensity of postoperative pain that will be assessed using Face, Legs, Activity, Cry and Consolability, minimum value 0 and maximum value 10, high scores means worse outcome (FLACC) pain scale

    Secondary Outcome Measures

    total analgesic consumption postoperative
    total amount of postoperative analgesic consumption

    Full Information

    First Posted
    August 23, 2022
    Last Updated
    September 9, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05536063
    Brief Title
    Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial
    Official Title
    Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    The aim of this study is to figure out the efficacy of dexamethasone addition to bupivacaine versus bupivacaine alone in bilateral erector spinae plane block on postoperative analgesia after pediatric cardiac surgeries
    Detailed Description
    The recently introduced ultrasound-guided interfascial plane block, bilateral erector spinae plane block (ESPB) is a viable option for management of postoperative pain after midline sternotomy. It is expected to provide an analgesic cover spanning the entire thorax at the desired dermatomes including the midline, which could prove beneficial for cardiac surgery through midline sternotomy. Indications for ESPB for postoperative analgesia in pediatric surgeries to date include thoracotomy, video-assisted thoracoscopic surgery, vascular ring repair and sternotomy. Dexamethasone is a synthetic glucocorticoid acting as an anti- inflammatory. It inhibits the release of inflammatory mediators such as interleukins and cytokines. Several studies have shown that a preoperative dose of dexamethasone added to local anesthetic agents has promising results in reducing postoperative pain and improving the quality of analgesia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Cardiac Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Experimental
    Arm Description
    bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) + dexamethasone 0.1 mg/kg for each side
    Arm Title
    Group C
    Arm Type
    No Intervention
    Arm Description
    control group will receive the standard analgesic regimen only
    Intervention Type
    Procedure
    Intervention Name(s)
    bilateral erector spinae plane block in pediatric cardiac surgeries
    Intervention Description
    The ESPB will be performed after induction of anesthesia, endotracheal tube insertion and before the start of operation, with the child in a right lateral decubitus position under aseptic precautions. A high frequency linear ultrasound transducer will be placed over the T4 transverse process lateral to the spinous process. After identifying the muscles above the hyperechoic transverse process image, a 5-cm 22 gauge needle will be inserted in-plane in a cephalo-caudad direction. The endpoint is defined as the needle pointing to the tip of transverse process piercing the erector spinae muscle. The local anesthetic will be deposited at this position, After careful negative aspiration, local anesthetic, according to study groups , The process will be repeated on thecontralateral side
    Primary Outcome Measure Information:
    Title
    postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
    Description
    The primary outcome of this study is the intensity of postoperative pain that will be assessed using Face, Legs, Activity, Cry and Consolability, minimum value 0 and maximum value 10, high scores means worse outcome (FLACC) pain scale
    Time Frame
    Postoperative pain assessment is performed using FLACC pain scale at fixed time intervasl for 48 hours post extubation,
    Secondary Outcome Measure Information:
    Title
    total analgesic consumption postoperative
    Description
    total amount of postoperative analgesic consumption
    Time Frame
    for 48 hours postextubation
    Other Pre-specified Outcome Measures:
    Title
    Beta endorphins levels
    Description
    comparison between preoperative and postoperative levels of B-endorphins
    Time Frame
    Blood samples for postoperative beta-endorphins at 2, 24, and 48 hours post-extubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II Undergoing cardiac surgical procedures through a midline sternotomyPreoperative ejection fraction <35% Exclusion Criteria: Low-cardiac-output syndrome Ventricular arrhythmia Preoperative inotropic support Known allergies to any of the study drugs Intubation for more than 3 hours or re-exploration A redo or emergency surgery Contraindications to regional anesthesia as coagulopathy and infection in site of block.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amonios khalil, assistan lecturer
    Phone
    01023466456
    Email
    amonios_khalil@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35489304
    Citation
    Karacaer F, Biricik E, Ilginel M, Tunay D, Topcuoglu S, Unlugenc H. Bilateral erector spinae plane blocks in children undergoing cardiac surgery: A randomized, controlled study. J Clin Anesth. 2022 Sep;80:110797. doi: 10.1016/j.jclinane.2022.110797. Epub 2022 Apr 28.
    Results Reference
    background
    PubMed Identifier
    24949192
    Citation
    Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
    Results Reference
    background

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    Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial

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