The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients With Advanced Knee Osteoarthritis.

Study Overview
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Brief Summary
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Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee 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 knee joint.

Official Title
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The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients With Advanced Knee Osteoarthritis. A Randomized, Double-blinded, Clinical Trial

Conditions
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Osteo Arthritis Knee, Osteoarthritis

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 gonarthrosis who failed to achieve satisfactory pain control (NRS>3) despite the use of NSAIDs, Paracetamol, and co-analgesics 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: 110 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: sham blocks Group 2: genicular nerve neurolysis
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sham blocks<br>US-guided Bilateral genicular nerve block with 0,9% NaCl | Drug: 0.9% Sodium chloride<br>* us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline<br>* Other names: Sham block;|
| Active Comparator: Genicular nerve neurolysis<br>US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol | Drug: 95% ethanol<br>* us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol<br>* Other names: neurolisis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS | The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | 7 days after procedure | 
| NRS | The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | 30 days after procedure | 
| NRS | The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | 3 months after procedure | 
| NRS | The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | 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. | 6 months after surgery | 
| neurological deficits | yes/no | 7 days after procedures | 
| neurological deficits | yes/no | 30 days after procedures | 
| neurological deficits | yes/no | 3 months after procedures | 
| neurological deficits | yes/no | 6 months after procedures | 
| 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 | 
| 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 surgery | 
| 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 surgery | 
| 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 surgery |