Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis

Phase 4

Completed

• Conditions: Osteoarthritis; Osteoarthritis, Hip
• Interventions: Drug: 0.9%sodium chloride; Drug: 95% ethanol

• Registration Number: NCT06087588
• Lead Sponsor: Poznan University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-10-11
• Study Start: 2023-10-17
• Study First Posted: 2023-10-18
• Status Verified: 2024-02
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-14
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham PENG block	0.9%sodium chloride	PENG block - 20ml 0,9% normal saline
PENG neurolysis	95% ethanol	PENG neurolysis with 5ml 95% ethanol

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	6 months after procedure	yes/no
total opioid consumption	6 months after procedure	milligrams of oral morphine per day

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland