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临床试验/NCT02007850
NCT02007850Unknown不适用

Effect of Continuous Femoral Analgesia on Quadriceps Muscle Strength-0.2% Ropivacaine Continuous Infusion Versus Patient Controlled Femoral Analgesia

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年2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
入组人数
36
试验地点
1
主要终点
Change of quadriceps muscle strength

研究概览

简要总结

Quadriceps muscle strength is an important determinant of quality of recovery in elderly patients after total knee arthroplasty. We try to compare the quadriceps muscle strength change between 0.2 % ropivacaine continuous fixed femoral infusion and patient controlled femoral analgesia group.

详细描述

Continuous femoral nerve analgesia technique is relatively safe, can be easily trained, and reduces significantly intravenous opioid consumption. These favorable features make it standard treatment option for postoperative knee pain. However, direct perineural local anesthetic effect is not only confined into pain fiber, but, the other sensory and motor nerve fibers. Therefore, unwanted motor weakness is accompanied. Quadriceps muscle strength, which is important determinant of physical function after knee arthroplasty, can be influenced in continuous femoral nerve block. Various local anesthetic infusion techniques have been suggested to minimize the change of quadriceps muscle strength. Decreasing local anesthetic concentrations affect not only degree of muscle weakness, but also reduces the quality of pain control. Different anatomic location of catheter tip, considering motor fiber in posterior part of femoral nerve, could not reduce motor weakness. In a study with continuous popliteal-sciatic nerve blocks after hallux valgus repair, repeated bolus administration seems to be more effective method for pain control without concurrent motor impairment. However, another study with continuous femoral nerve block in healthy volunteers, hourly repeated bolus dose of 5 ml of 0.1% ropivacaine failed to spare motor block. Previously, our institution standard technique is fixed continuous infusion of 0.2% ropivacaine and concomitant intravenous patient controlled fentanyl. Because physical therapy of our institution, usually starts with the 2nd day of operation, so, we assume that continuous fixed infusion may result in more drug accumulation near nerve fiber. So, patient controlled mode of femoral analgesia could be better choice for initiation of physical therapy. At the same time, comparison between patient controlled analgesia and continuous infusion is not fully elucidated until recently. Therefore, in this study, we try to compare quadriceps muscle strength change between continuous infusion and patient controlled femoral analgesia in patients undergoing total knee replacement arthroplasty. Secondary outcomes include sensory effect in femoral nerve distribution, pain scores, iv fentanyl consumption, and other adverse effects.

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
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 21, or < 80 years old- men and women
  • primary, unilateral total knee replacement surgery
  • spinal anesthesia

排除标准

  • general anesthesia
  • secondary knee replacement surgery
  • patient refusal for continuous femoral nerve analgesia technique
  • abnormal coagulation profile, e.g. Prothrombin time international normalized ratio > 1.5, activated partial thrombin time > 50 sec
  • within 5 days after termination oral antiplatelet agent
  • Body mass index>45
  • impaired renal function
  • infection near femoral area
  • previous injury near femoral area
  • neurologic dysfunction in lower limb
  • previous adverse drug reaction for local anesthetics
  • American society of anesthesiologists (ASA) class III, iV or V

研究组 & 干预措施

ropivacaine continuous mode

Placebo Comparator

0.2% ropivacaine 8 ml/hr through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl

干预措施: ropivacaine (Drug)

ropivacaine patient controlled mode

Active Comparator

0.2% ropivacaine patient controlled mode, basal rate 4 ml/hr, bolus 4 ml, lockout 60 minutes through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl

干预措施: ropivacaine (Drug)

结局指标

主要结局

Change of quadriceps muscle strength

时间窗: Baseline, Postoperative 2nd day

maximum voluntary isometric contraction of quadriceps femoris with hand held manometry

次要结局

  • sensory changes in femoral nerve distribution(postoperative 2 day)
  • pain scores(postoperative 2 day)
  • intravenous fentanyl consumption(postoperative 2 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hae Wone Chang

Clinical Associate Professor

Seoul National University Hospital

研究点 (1)

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