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临床试验/NCT02695654
NCT02695654已完成不适用

Effectiveness of Ultrasound Guided Adductor Canal Blockade With Levobupivacaine and Clonidine on Chronic Pain in Knee Osteoarthritis

Mensur Salihovic1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
1
主要终点
Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS -11)

研究概览

简要总结

Adductor canal block has become popular as effective mean for pain relief following knee surgery.This block has not been checked in chronic pain patients.The purpose of this study is to assess the efficacy and safety of adductor canal block on chronic knee pain in patients with knee osteoarthritis.

详细描述

Knee osteoarthritis is serious epidemiologic problem. Knee prosthesis is successful treatment for many of patients with advanced knee osteoarthritis but there are important numbers of patients, which are not appropriate candidates for such surgery treatment. For them ,any treatment which could relieve pain in their knee would have good impact on quality of life. Adductor canal block is successfully used for relieving postoperative pain after knee surgery. Official approval from ethics committee of Republic Slovenia was obtained for this study. After being informed about the study and potential risks, all patients giving written informed consent will undergo an orthopedic examination and those with confirmed diagnosis of knee osteoarthritis lasted more than 6 months will be included in the study. Prior to start they filled Knee injury and osteoarthritis outcome(KOOS) form and estimate maximal and minimal intensity of pain in the knee .They repeat self assessment of pain at the same manner using 11 point numeric rating score(NRS) 1 week and 1 month after blockade.Measurement of maximum voluntary isometric contraction of quadriceps muscle (MVIC) ,time up and go test(TUG) and 30s chair stand test are performed by physiotherapist before block of adductor canal on the ipsilateral leg ,1 hour,1 week and 1 month after block..Block of adductor canal is performed by the same and trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and 100 mcg Clonidine mixed in the same syringe.At the conclusion of study patients filled the Knee injury and osteoarthritis outcome(KOOS) form once again.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients Had pain in knee at least 6 months before the study Knee osteoarthritis chronic pain was diagnosed based on medical history, knee X- ray and orthopedic examination.
  • A sufficient level of education to understand study procedures and be able to communicate with site personnel

排除标准

  • Any cardiovascular, hepatic, or renal conditions that would compromise participation, in the opinion of the investigator
  • Severe neurologic conditions interfere with knee condition
  • Narcotic dependent (opioid intake more than 3 months and more than 30 mg of daily oral morphine equivalents)
  • Coexisting severe hematological disorder or with deranged coagulation parameters
  • Psychiatric illnesses
  • Allergy to any of the drugs used in the study
  • Infection or malignancy at the site of block
  • Any active systemic infection

研究组 & 干预措施

Chronic pain in knee osteoarthritis

Ultrasound guided single shot Adductor canal block with 0,25% Levobupivacaine 14 ml and 100 mcg Clonidine

干预措施: Levobupivacaine (Drug)

Chronic pain in knee osteoarthritis

Ultrasound guided single shot Adductor canal block with 0,25% Levobupivacaine 14 ml and 100 mcg Clonidine

干预措施: Clonidine (Drug)

结局指标

主要结局

Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS -11)

时间窗: Baseline ,1 hour,1 week and 4 weeks

Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain

次要结局

  • Maximum voluntary isometric contraction of quadriceps muscle (MVIC)(prior, 1 hour ,1 week and 1 month after block measured by handheld dynamometer)
  • The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block(Baseline and 1 month following adductor canal block)
  • Satisfaction of patient(1 month after block)
  • Timed up to go test(TUG)(prior, 1 hour ,1 week and 1 month after block)

研究者

发起方
Mensur Salihovic
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mensur Salihovic

Principal investigator

University Medical Centre Ljubljana

研究点 (1)

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