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临床试验/CTRI/2022/04/041726
CTRI/2022/04/041726已完成不适用

“Comparison of intrathecal hyperbaric Ropivacaine 0.75% and hyperbaric Bupivacaine 0.5% in lower limb orthopaedic surgery-A prospective randomised double blind comparative studyâ€

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年4月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Duration of Analgesia

研究概览

简要总结

Our original study  is comparison of intrathecal 0.5 % bupivacaine heavy  and 0.75% ropivacaine heavy  for lower limb surgeries  in terms of duration of analgesia,  block characterstics.  kindly consider our study for ctri registration.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and 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 with ASA physical status Grade I and II of either sex.
  • Patients in the age group of 18-60 years.
  • Posted for lower limb orthopedic surgeries under spinal anaesthesia.

排除标准

  • Patients posted for emergency surgeries.
  • Pregnant patients.
  • Patients having coagulation abnormalities, platelet count <75,000, INR >1.5, or on anticoagulants.
  • Patients having systemic illness (severe hypovolemia, raised intracranial pressure, neuromuscular diseases, ischemic/ valvular/ congenital heart diseases, psychiatric, hematological disorder).
  • Patients having any absolute contraindications for spinal anesthesia.
  • Any allergy to study drugs or local anaesthetic drugs.
  • Short stature (height <150cms), with spinal deformity.

结局指标

主要结局

Duration of Analgesia

时间窗: 4 hours postoperatively

次要结局

  • onset and duration of sensory block, onset and duration of motor block and hemodynamic parameters.(Intraoperative (3-4 hours))

研究者

发起方
Department of Anaesthesiology
申办方类型
Government medical college

研究点 (1)

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