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PENG neurolysis in advanced osteoarthritis of the hip joint.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham PENG block | Active Comparator | PENG block - 20ml 0,9% normal saline |
|
| PENG neurolysis | Active Comparator | PENG neurolysis with 5ml 95% ethanol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9%sodium chloride | Drug | PENG sham block with 20ml 0,9% normal saline |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Wieczorowska-Tobis, Prof.dr hab | Poznań University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | Poznań | 61-701 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40480912 | Derived | Reysner M, Reysner T, Kowalski G, Mularski A, Daroszewski P, Wieczorowska-Tobis K. Chemical ablation of pericapsular nerve group with 95% ethanol for pain relief and quality of life in patients with hip osteoarthritis: a prospective, double-blinded, randomised, controlled trial. Br J Anaesth. 2025 Aug;135(2):382-389. doi: 10.1016/j.bja.2025.04.045. Epub 2025 Jun 6. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000431 | Ethanol |
| D009407 | Nerve Block |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Group 1 - PENG sham block Group 2 - PENG neurolysis 95% ethanol
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| 95% ethanol | Drug | PENG neurolysis with 2.5ml of 95% ethanol |
|
|
| 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 |
| D017670 |
| Sodium Compounds |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |