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Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Primary Purpose

Scoliosis Idiopathic, Scoliosis; Adolescence

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.9% sodium chloride
Dexamethasone
Dexmedetomidine
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: children scheduled for idiopathic scoliosis surgery age >10 and <18 years Exclusion Criteria: age < 10 years age < 18 years infection at the site of the regional blockade coagulation disorders immunodeficiency ASA= or >4 steroid medication in regular use

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo

    Dexamethasone

    Dexmedetomidine

    Arm Description

    0.2% ropivacaine for erector spinae plane block

    0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block

    0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block

    Outcomes

    Primary Outcome Measures

    first need of opiate
    Time after surgery when the patient needs opiate for the first time

    Secondary Outcome Measures

    Opioid consumption
    Total opiate consumption after surgery
    Numerical Rating Scale [range 0:10]
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Numerical Rating Scale [range 0:10]
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Numerical Rating Scale [range 0:10]
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Numerical Rating Scale [range 0:10]
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Numerical Rating Scale [range 0:10]
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Numerical Rating Scale [range 0:10]
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    NLR
    Neutrophil-to-lymphocyte ratio
    PLR
    Platelet-to-lymphocyte ratio

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Poznan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06086431
    Brief Title
    Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
    Official Title
    Dexamethasone vs. Dexmedetomidine for Erector Spine Plane Block in Pain Management After Pediatric Idiopathic Scoliosis Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poznan University of Medical Sciences

    4. Oversight

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

    5. Study Description

    Brief Summary
    Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
    Detailed Description
    This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. After scoliosis surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect. There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children. In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic. The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scoliosis Idiopathic, Scoliosis; Adolescence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    0.2% ropivacaine for erector spinae plane block
    Arm Title
    Dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
    Arm Title
    Dexmedetomidine
    Arm Type
    Active Comparator
    Arm Description
    0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% sodium chloride
    Other Intervention Name(s)
    placebo
    Intervention Description
    administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block
    Primary Outcome Measure Information:
    Title
    first need of opiate
    Description
    Time after surgery when the patient needs opiate for the first time
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Opioid consumption
    Description
    Total opiate consumption after surgery
    Time Frame
    48 hours
    Title
    Numerical Rating Scale [range 0:10]
    Description
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Time Frame
    4 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Time Frame
    8 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Time Frame
    12 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Time Frame
    16 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Time Frame
    20 hours after surgery
    Title
    Numerical Rating Scale [range 0:10]
    Description
    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
    Time Frame
    24 hours after surgery
    Title
    NLR
    Description
    Neutrophil-to-lymphocyte ratio
    Time Frame
    24 and 48 hours after surgery
    Title
    PLR
    Description
    Platelet-to-lymphocyte ratio
    Time Frame
    24 and 48 hours after surgery]

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children scheduled for idiopathic scoliosis surgery age >10 and <18 years Exclusion Criteria: age < 10 years age < 18 years infection at the site of the regional blockade coagulation disorders immunodeficiency ASA= or >4 steroid medication in regular use
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Małgorzata Domagalska, Ph.D.
    Phone
    +48 608762068
    Email
    m.domagalska@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomasz Kotwicki, Prof.dr hab.
    Organizational Affiliation
    Poznan University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

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