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PENG Block vs. ESP Block for Pediatric Hip Surgery

Primary Purpose

Hip Dysplasia, Hip Injuries, Hip Fractures

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pericapsular nerve group block using 0.2% ropivacaine
Erector Spinae Plane Block using 0.2% ropivacaine
Standard care
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia

Eligibility Criteria

2 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - pediatric patients aged between 0-12 years who will undergo hip surgery Exclusion Criteria: a history of chronic pain use of gabapentin/pregabalin for > 3 months opioid use > 1 repeated opioid prescription in the last three months morbid obesity (BMI > 99th percentile) Infection at block application area coagulopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Control group

    Pericapsular nerve group block (PENG) group

    Erector Spinae Plane Block (ESPB) group

    Arm Description

    regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine

    regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + PENG block - 0.5mL/kg 0.2% ropivacaine, max. 20mL

    regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + ESP block - 0.5mL/kg 0.2% ropivacaine, max. 20mL

    Outcomes

    Primary Outcome Measures

    FLACC score
    The FLACC scale or Face, Legs, Activity, Cry, Controllability Scale is used to assess pain for children between the ages of 2 months and seven years or individuals unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain.

    Secondary Outcome Measures

    NLR
    neutrophil-to-lymphocyte ratio
    PLR
    platelet-to-lymphocyte ratio
    total opioid consumption
    morphine equivalents in miligrams

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Poznan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06087549
    Brief Title
    PENG Block vs. ESP Block for Pediatric Hip Surgery
    Official Title
    PENG Block vs. ESP Block for Pediatric Hip Surgery. A Randomized, Prospective Double-blinded Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2023 (Anticipated)
    Primary Completion Date
    December 20, 2023 (Anticipated)
    Study Completion Date
    January 30, 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

    5. Study Description

    Brief Summary
    The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.
    Detailed Description
    The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. In addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Dysplasia, Hip Injuries, Hip Fractures, Hip Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Three groups: Group I -control Group II - PENG block Group III - ESP block
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Patients will be randomly allocated to receive ultrasound-guided PENG block, ESP block, or only spinal anesthesia by computer software 1:1:1. A researcher who will not involve in the study will prepare the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist will follow management to open the envelopes shortly before the nerve block performance to reveal the group allocation and perform the procedure according to the assignment. The patients and their anesthesia team, surgeon, operating room staff, and parents will be masked to the study group allocation. Group blinding unmasking will only occur once the statistical analysis is complete.
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine
    Arm Title
    Pericapsular nerve group block (PENG) group
    Arm Type
    Active Comparator
    Arm Description
    regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + PENG block - 0.5mL/kg 0.2% ropivacaine, max. 20mL
    Arm Title
    Erector Spinae Plane Block (ESPB) group
    Arm Type
    Active Comparator
    Arm Description
    regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + ESP block - 0.5mL/kg 0.2% ropivacaine, max. 20mL
    Intervention Type
    Drug
    Intervention Name(s)
    Pericapsular nerve group block using 0.2% ropivacaine
    Intervention Description
    Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)
    Intervention Type
    Drug
    Intervention Name(s)
    Erector Spinae Plane Block using 0.2% ropivacaine
    Intervention Description
    Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Other Intervention Name(s)
    No erector spinae block and no pericapsular nerve group block
    Intervention Description
    No erector spinae block and no pericapsular nerve group block
    Primary Outcome Measure Information:
    Title
    FLACC score
    Description
    The FLACC scale or Face, Legs, Activity, Cry, Controllability Scale is used to assess pain for children between the ages of 2 months and seven years or individuals unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain.
    Time Frame
    48 hours after surgery
    Secondary Outcome Measure Information:
    Title
    NLR
    Description
    neutrophil-to-lymphocyte ratio
    Time Frame
    48 hours after surgery
    Title
    PLR
    Description
    platelet-to-lymphocyte ratio
    Time Frame
    48 hours after surgery
    Title
    total opioid consumption
    Description
    morphine equivalents in miligrams
    Time Frame
    48 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - pediatric patients aged between 0-12 years who will undergo hip surgery Exclusion Criteria: a history of chronic pain use of gabapentin/pregabalin for > 3 months opioid use > 1 repeated opioid prescription in the last three months morbid obesity (BMI > 99th percentile) Infection at block application area coagulopathy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Malgorzata Domagalska, Ph.D.
    Phone
    0048608762068
    Email
    m.domagalska@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomasz Kotwicki, Prof.dr hab
    Organizational Affiliation
    Poznań University of Medical Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    PENG Block vs. ESP Block for Pediatric Hip Surgery

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