跳至主要内容
临床试验/CTRI/2022/09/045396
CTRI/2022/09/045396尚未招募不适用

Dose finding study of 0.75% hyperbaric ropivacaine for unilateral subarachnoid block in lower limb orthopedic surgeries

Department of Anesthesiology1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
102
试验地点
1
主要终点
To determine the ideal dosage of hyperbaric 0.75% ropivacaine for unilateral subarachnoid block in orthopedic lower limb surgeries by assessing the maximum sensory and motor block o both operative and non operative sides by each individual dosage

研究概览

简要总结

Subarachnoid block is one of the important techniques of anesthesia for performing orthopedic lower limb surgeries as it can produce adequate sensory, motor and sympathetic block in a rapid manner. This can become more cost effective with unilateral block as hemodynamic effects, post operative urinary retention can be minimized leading to better patient satisfaction and faster discharge. Ropivacaine is an alternative to bupivacaine for subarachnoid block as it has less chance of cardiotoxicity as well as neurotoxicity. Although 0.5% Ropivacaine in isobaric or hyperbaric form has been used in lower limb surgeries , very less information is available regarding 0.75% Ropivacaine for unilateral block for orthopedic lower limb surgeries. The ideal dose of 0.75% ropivacaine for unilateral subarachnoid block for this type of orthopedic surgeries can be ascertained by assessing the maximum and minimum sensory and motor block on the operative and nonoperative sides and its effect on hemodynamics.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant 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

  • Body weight.
  • 40-85 kg Height.
  • 150-180 cm ASA 1, 2 Duration of surgery.
  • less than 1 hour.

排除标准

  • Unwilling for subarachnoid block, skin infection at the site of intrathecal injection, allergy to the study drug, coagulopathy, taking anticoagulant drugs, hypovolemia, fixed cardiac output disease, undetermined neurologic disease, spine deformity.

结局指标

主要结局

To determine the ideal dosage of hyperbaric 0.75% ropivacaine for unilateral subarachnoid block in orthopedic lower limb surgeries by assessing the maximum sensory and motor block o both operative and non operative sides by each individual dosage

时间窗: baseline, 20 minutes after the injection for subarachnoid block, 2 hours after the sbaracoid block

次要结局

  • hemodynamic effects of the 3 different doses for unilateral subarachnoid block(during the surgery)

研究者

申办方类型
Government medical college

研究点 (1)

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