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临床试验/NCT01158586
NCT01158586Unknown4 期

Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine

United Christian Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Pain score

研究概览

简要总结

Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain relief technique after having total knee replacement operation(1,4). Patient controlled epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2) and results in reduced epidural analgesic requirements(3). Besides, it also bear the advantage of avoidance of overdose, reduction of waiting times and involvement of patients in their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic using in epidural analgesia which has been proven to be safe and effective(4). 0.2% Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong, which has been proved to be safe, effective and may be better value for money. These two drugs has been proven to have similar analgesic potency in using as EA for postoperative pain relief for other operation(5,6,7) and for orthropaedics operation but in different concentration(4). Concerns have been raised about the introduction of the levobupivacaine in the departmental protocol. Objectives of this study are A)to determine the equivalence of two local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens.

The null hypothesis is that the difference of analgesic effect, presented with visual analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the threshold of 9 mm VAS. (8,9,10)

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • > 18 years old, ASA I -III and
  • Undergoing total knee arthroplasty
  • Combine spinal-epidural anaesthesia

排除标准

  • Known hypersensitivity to amide-type local anaesthetics
  • Known hypersensitivity to opioids
  • Known history of severe cardiovascular, renal, hepatic, neurological or psychiatric disease as judged by the investigator
  • Known history of peripheral neuropathies
  • Those receiving chronic analgesic therapy, or any contraindication for epidural analgesia (e.g. clotting disorders, or history of lumbar surgery)
  • Inability to perform a pain score, or pregnancy or lactation

研究组 & 干预措施

Levobupivacaine

Experimental

patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl

干预措施: Levobupivacaine (Drug)

Ropivacaine

Active Comparator

patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl

干预措施: Levobupivacaine (Drug)

结局指标

主要结局

Pain score

时间窗: 48hours after start epidural analgesia

as well as complications from epidural analgesia are also going to record and monitored

次要结局

  • cost/treatment(48hours)

研究者

申办方类型
Other

研究点 (1)

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