Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis

Study Overview
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Brief Summary
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PENG neurolysis in advanced osteoarthritis of the hip joint.

Detailed Description
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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.

Official Title
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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.

Conditions
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Osteoarthritis, Osteoarthritis, Hip

Intervention / Treatment
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* Drug: 0.9%sodium chloride
* Drug: 95% ethanol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 - PENG sham block Group 2 - PENG neurolysis 95% ethanol
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sham PENG block<br>PENG block - 20ml 0,9% normal saline | Drug: 0.9%sodium chloride<br>* PENG sham block with 20ml 0,9% normal saline<br>* Other names: Sham block;|
| Active Comparator: PENG neurolysis<br>PENG neurolysis with 5ml 95% ethanol | Drug: 95% ethanol<br>* PENG neurolysis with 2.5ml of 95% ethanol<br>* Other names: neurolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days after procedure | 
| 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. | 30 days after procedure | 
| 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. | 3 months after procedure | 
| 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. | 6 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days after procedure | 
| 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 | 30 days after procedure | 
| 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 | 3 months after procedure | 
| 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 | 6 months after procedure | 
| neurological deficits | yes/no | 7 days after procedure | 
| neurological deficits | yes/no | 30 days after procedure | 
| neurological deficits | yes/no | 3 months after procedure | 
| neurological deficits | yes/no | 6 months after procedure | 
| total opioid consumption | milligrams of oral morphine per day | 7 days after procedure | 
| total opioid consumption | milligrams of oral morphine per day | 30 days after procedure | 
| total opioid consumption | milligrams of oral morphine per day | 3 months after procedure | 
| total opioid consumption | milligrams of oral morphine per day | 6 months after procedure |