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临床试验/NCT03679897
NCT03679897已完成4 期

0.25% Levobupivacaine Versus 0.375% Ropivacaine: a Comparative Study in Ultrasound-Guided Infraclavicular Brachial Plexus Block

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年9月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
46
试验地点
1
主要终点
onset time of sensory block

研究概览

简要总结

Infraclavicular brachial plexus block has been used more frequently with the development of high-resolution ultrasound. Compared with peripheral nerve block using landmark technique or nerve stimulator technique, ultrasound-guided peripheral nerve block decreases the required dose of local anesthetics. As the dose of the drug used decreases, the systemic toxic effects of local anesthetics are reduced. However, the decreased dose of the drugs might have influence on the onset time of local anesthetics. Thus, the investigator aimed to evaluated the onset time of the two equipotent local anesthetics, 0.375% ropivacaine and 0.25% levobupivacaine.

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
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status 1-3
  • Patients undergoing upper extremity surgery with infraclavicular brachial plexus block

排除标准

  • Patients who do not agree to participate in clinical trial
  • Patients presenting with neurological deficits of the upper arm, severe coagulopathy, chronic renal failure, cardiopulmonary compromise, cerebral vascular disease, hypersensitivity to hyaluronidase or local anesthetics or local infection at the site of the infraclavicular block, pregnancy

研究组 & 干预措施

Ropivacaine group

Experimental

BPB with 0.375% ropivacaine solution

干预措施: Ropivacaine solution (Drug)

Levobupivacaine group

Active Comparator

BPB with 0.25% levobupivacaine solution

干预措施: Levobupivacaine solution (Drug)

结局指标

主要结局

onset time of sensory block

时间窗: up to 40 minutes

sensory block of 4 nerves(radial, median, ulnar, musculocutaneous nerve) was assessed with pin-prick test every 5 minutes till 40 minutes from the completion of drug injection

次要结局

  • duration of analgesia(24 hours)
  • onset time of motor block(up to 40 minutes)

研究者

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

Hajung Kim

Clinical Instructor

Asan Medical Center

研究点 (1)

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