NCT06087588已完成4 期
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.
Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NRS score
研究概览
简要总结
PENG neurolysis in advanced osteoarthritis of the hip joint.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •suspected or diagnosed opioid dependence syndrome
- •active cancer
研究组 & 干预措施
sham PENG block
Active Comparator
PENG block - 20ml 0,9% normal saline
干预措施: 0.9%sodium chloride (Drug)
PENG neurolysis
Active Comparator
PENG neurolysis with 5ml 95% ethanol
干预措施: 95% ethanol (Drug)
结局指标
主要结局
NRS score
时间窗: 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.
次要结局
- Health Questionnaire (EQ-5D-5L)(6 months after procedure)
- neurological deficits(6 months after procedure)
- total opioid consumption(6 months after procedure)
研究者
研究点 (1)
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