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Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis (PENG)

Primary Purpose

Osteoarthritis, Osteoarthritis, Hip

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.9%sodium chloride
95% ethanol
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study patients with coxarthrosis or gonarthrosis who failed to achieve satisfactory pain control (NRS>3) despite the use of NSAIDs, Paracetamol, and co-analgetics Age of patients: from 18 to 110 years of age. Caucasian patients can give informed, complete, written consent. Exclusion Criteria: suspected or diagnosed opioid dependence syndrome active cancer dementia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    sham PENG block

    PENG neurolysis

    Arm Description

    PENG block - 20ml 0,9% normal saline

    PENG neurolysis with 5ml 95% ethanol

    Outcomes

    Primary Outcome Measures

    NRS score
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
    NRS score
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
    NRS score
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
    NRS score
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

    Secondary Outcome Measures

    Health Questionnaire (EQ-5D-5L)
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    Health Questionnaire (EQ-5D-5L)
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    Health Questionnaire (EQ-5D-5L)
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    Health Questionnaire (EQ-5D-5L)
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    neurological deficits
    yes/no
    neurological deficits
    yes/no
    neurological deficits
    yes/no
    neurological deficits
    yes/no
    total opioid consumption
    milligrams of oral morphine per day
    total opioid consumption
    milligrams of oral morphine per day
    total opioid consumption
    milligrams of oral morphine per day
    total opioid consumption
    milligrams of oral morphine per day

    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
    NCT06087588
    Brief Title
    Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis
    Acronym
    PENG
    Official Title
    The Impact of the Pericapsular Nerve Group Block (PENG) Chemical Neurolysis on the Quality of Life of Patients With Advanced Hip Osteoarthritis. 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 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    February 28, 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
    PENG neurolysis in advanced osteoarthritis of the hip joint.
    Detailed Description
    The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the hip joint.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Osteoarthritis, Hip

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1 - PENG sham block Group 2 - PENG neurolysis 95% ethanol
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sham PENG block
    Arm Type
    Active Comparator
    Arm Description
    PENG block - 20ml 0,9% normal saline
    Arm Title
    PENG neurolysis
    Arm Type
    Active Comparator
    Arm Description
    PENG neurolysis with 5ml 95% ethanol
    Intervention Type
    Drug
    Intervention Name(s)
    0.9%sodium chloride
    Other Intervention Name(s)
    Sham block
    Intervention Description
    PENG sham block with 20ml 0,9% normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    95% ethanol
    Other Intervention Name(s)
    neurolysis
    Intervention Description
    PENG neurolysis with 2.5ml of 95% ethanol
    Primary Outcome Measure Information:
    Title
    NRS score
    Description
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
    Time Frame
    7 days after procedure
    Title
    NRS score
    Description
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
    Time Frame
    30 days after procedure
    Title
    NRS score
    Description
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
    Time Frame
    3 months after procedure
    Title
    NRS score
    Description
    The NRS (Numeric Pain Rating Scale) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
    Time Frame
    6 months after procedure
    Secondary Outcome Measure Information:
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    Time Frame
    7 days after procedure
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    Time Frame
    30 days after procedure
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    Time Frame
    3 months after procedure
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
    Time Frame
    6 months after procedure
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    7 days after procedure
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    30 days after procedure
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    3 months after procedure
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    6 months after procedure
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    7 days after procedure
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    30 days after procedure
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    3 months after procedure
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    6 months after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study patients with coxarthrosis or gonarthrosis who failed to achieve satisfactory pain control (NRS>3) despite the use of NSAIDs, Paracetamol, and co-analgetics Age of patients: from 18 to 110 years of age. Caucasian patients can give informed, complete, written consent. Exclusion Criteria: suspected or diagnosed opioid dependence syndrome active cancer dementia
    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
    Katarzyna Wieczorowska-Tobis, Prof.dr hab
    Organizational Affiliation
    Poznań University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis

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