Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy
Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia
The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.
An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.
This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).
We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Marburg、德国、35037
- University of Marburg Department of Anaesthesia And Intensive Care Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients with knee replacement therapy and general anaesthesia
- informed consent
- preoperative "timed up and go" test performable
Exclusion Criteria:
- emergency patients
- BMI > 40 kg/m2
- American Society of Anaesthesiologists physical status (ASA) 4-5
- severe chronic obstructive pulmonary disease (COPD)
- rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
- nerve injury of lumbosacral plexus
- coagulopathy with bleeding tendency
- not capable of speaking or understanding german or english
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Continuous Adductor Canal Block (CACB)
Continuous Adductor Canal block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
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有源比较器:Continuous Femoral Nerve Block (CFNB)
Continuous Femoral Nerve Block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Timed-Up and Go-test for mobility evaluation
大体时间:third postoperative day
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The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
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third postoperative day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Scores
大体时间:6, 24, 48, 72 hours postoperative
|
Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain
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6, 24, 48, 72 hours postoperative
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Quadriceps strength
大体时间:6, 24, 28, 72 hours postoperative
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Numeric Scale (0-5)
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6, 24, 28, 72 hours postoperative
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Ropivacaine consumption (each catheter)
大体时间:24, 48, 72 hours postoperative
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Measurement of the total amount
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24, 48, 72 hours postoperative
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CAS (Cumulated Ambulation Score)
大体时间:24,48,72 hours postoperative
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Cumulated Ambulation Score is calculated with routine data.
Measurement for ambulation ability
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24,48,72 hours postoperative
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Mobility Score (MoSc)
大体时间:24,48,72 hours postoperative
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Is calculated with routine data.
Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)
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24,48,72 hours postoperative
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Analgesic regimen
大体时间:preop and 0, 6 , 24, 48, 48 hours postoperative
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Documentation of analgesic prescriptions and rescue medications during postoperative course
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preop and 0, 6 , 24, 48, 48 hours postoperative
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合作者和调查者
调查人员
- 研究主任:Karolin Piechowiak, Dr、Dept. of Anesthesia And Intensiv Care Medicine University of Marburg
- 研究主任:Thorsten Steinfeldt, Prof Dr、Dept. of Anesthesia And Intensive Care Medicine University of Marburg
- 研究主任:Thomas Wiesmann, Dr、Dept. of Anesthesia And Intensive Care Medicine University of Marburg
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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