PENG: Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis
Study Details
Study Description
Brief Summary
PENG neurolysis in advanced osteoarthritis of the hip joint.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: sham PENG block PENG block - 20ml 0,9% normal saline |
Drug: 0.9%sodium chloride
PENG sham block with 20ml 0,9% normal saline
Other Names:
|
| Active Comparator: PENG neurolysis PENG neurolysis with 5ml 95% ethanol |
Drug: 95% ethanol
PENG neurolysis with 2.5ml of 95% ethanol
Other Names:
|
Outcome Measures
Primary Outcome Measures
- NRS score [7 days after procedure]
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 [30 days after procedure]
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 [3 months after procedure]
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 [6 months after procedure]
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) [7 days after procedure]
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) [30 days after procedure]
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) [3 months after procedure]
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) [6 months after procedure]
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 [7 days after procedure]
yes/no
- neurological deficits [30 days after procedure]
yes/no
- neurological deficits [3 months after procedure]
yes/no
- neurological deficits [6 months after procedure]
yes/no
- total opioid consumption [7 days after procedure]
milligrams of oral morphine per day
- total opioid consumption [30 days after procedure]
milligrams of oral morphine per day
- total opioid consumption [3 months after procedure]
milligrams of oral morphine per day
- total opioid consumption [6 months after procedure]
milligrams of oral morphine per day
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Poznan University of Medical Sciences
Investigators
- Study Director: Katarzyna Wieczorowska-Tobis, Prof.dr hab, Poznań University of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5/2023