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Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Primary Purpose

Wrist Disease, Hand Injuries, Wrist Injuries

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
0.1mg/kg Dexamethasone
0.05mg/kg Dexamethasone
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Disease

Eligibility Criteria

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

Inclusion Criteria: children scheduled for hand/wrist surgery body weight > 5kg Exclusion Criteria: 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

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo

    0.1mg/kg Dexamethasone

    0,05mg/kg dexamethasone

    Arm Description

    0.2% ropivacaine for supraclavicular brachial plexus block

    0,1mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus block

    0,05mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus 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
    Pain score
    children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)
    Blood glucose
    Blood glucose every 24 hour during hospitalization
    NLR
    Neutrophil-to-lymphocyte ratio
    PLR
    Platelet-to-lymphocyte ratio
    Mobilisation
    Finger movement every 4 hours

    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
    NCT06086392
    Brief Title
    Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
    Official Title
    Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    September 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 Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
    Detailed Description
    This study is proposed to explore the effect of perineurial Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery. After hand and wrist 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, 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 use has been compared in adults. However, there is a massive lack of research regarding children. In this study, investigators compare different doses of perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic. The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously 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
    Wrist Disease, Hand Injuries, Wrist Injuries, Hand Disease, Hand Injuries and Disorders

    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
    Active Comparator
    Arm Description
    0.2% ropivacaine for supraclavicular brachial plexus block
    Arm Title
    0.1mg/kg Dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    0,1mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus block
    Arm Title
    0,05mg/kg dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    0,05mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus block
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    0.9% sodium chloride
    Intervention Description
    administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the supraclavicular brachial plexus block
    Intervention Type
    Drug
    Intervention Name(s)
    0.1mg/kg Dexamethasone
    Other Intervention Name(s)
    large dose dexamethasone
    Intervention Description
    administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the supraclavicular brachial plexus block
    Intervention Type
    Drug
    Intervention Name(s)
    0.05mg/kg Dexamethasone
    Other Intervention Name(s)
    small dose dexamethasone
    Intervention Description
    administration of 0.5ml/kg of 0,2% ropivacaine with 0.05mg/kg Dexamethasone for the supraclavicular brachial plexus 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
    Pain score
    Description
    children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)
    Time Frame
    4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery
    Title
    Blood glucose
    Description
    Blood glucose every 24 hour during hospitalization
    Time Frame
    24 and 48 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
    Title
    Mobilisation
    Description
    Finger movement every 4 hours
    Time Frame
    4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children scheduled for hand/wrist surgery body weight > 5kg Exclusion Criteria: 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
    Malgorzata Domagalska, Ph.D.
    Phone
    +48 608762068
    Email
    m.domagalska@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leszek Romanowski, Prof.dr hab.
    Organizational Affiliation
    Poznan University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

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