跳至主要内容
临床试验/CTRI/2023/08/056823
CTRI/2023/08/056823招募中不适用

Comparison of efficacy of bupivacaine (0.125%) with fentanyl (0.7 mcg/kg) versus morphine (2mg) through epidural for post operative analgesia in total knee arthroplasty.

kempegowda institute of medical science1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年12月9日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
to compare & determine the postoperative analgesic efficacy of bupivacaine 0.125 % with fentanyl versus morphine 2 mg through epidural in tka cases

研究概览

简要总结

International association for the study of pain (IASP) defines pain as "An unpleasent sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage".Ineffectively managing pain in the postoperative period often leads to unpleasent consequences like increased cost of care, slower recovery, development of chronic pain.Postoperative pain relief can be achieved by a number of techniques such as intravenous patient controlled analgesia with Opioids,NSAIDS, peripheral local anaesthetics and epidural analgesia. Neuraxial anesthesia includes all the central blocks -  spinal, epidural, and caudal spaces. While it is an invaluable adjunct , it is now even occasionally a good alternative to general anesthesia. Knowledge about the drug used for the epidural block becomes primarily important because it affects duration, desire to have a sensory and/or motor block etc.Epidural administration of local anesthetics and opiates has proven to be effective in the treatment of intra and postoperative pain .Hence, in this sudy we will compare and determine the postoperative analgesic efficacy  of bupivacaine 0.125% with fentanyl 0.7mcg/kg  versus morphine 2mg through epidural in total knee arthroplasty cases.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 60 years posted for elective total knee arthroplasty under combined spinal epidural.
  • American Society of Anaesthesiology (ASA) physical status 1 and 2.

排除标准

  • EXCLUSION CRITERIA: a) Patient refusal for the study.
  • b) Has any known allergy or contraindication to the drugs or neuraxial anaesthesia.
  • c) Has received chronic opioids.
  • d) Has uncontrolled diabetic mellitus,hepatic or renal impairment e) Pregnant or lactating.
  • f) Duration of surgery extending to more than 4 hours.
  • g) Local infection at site of injection.

结局指标

主要结局

to compare & determine the postoperative analgesic efficacy of bupivacaine 0.125 % with fentanyl versus morphine 2 mg through epidural in tka cases

时间窗: 4th hourly for 24 hours

次要结局

  • to estimate number of rescue analgesia required(to study the side effects of drugs when administered through epidural)

研究者

发起方
kempegowda institute of medical science
申办方类型
Private medical college

研究点 (1)

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