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临床试验/NCT03265886
NCT03265886已完成不适用

The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics

Mansoura University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Time to onset of sensory block

研究概览

简要总结

Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.

The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.

详细描述

The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular plexus block characteristics as regard sensory block onset time, motor block onset time, duration of sensory and motor block , effective duration of analgesia, total analgesics requirement, complications and side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

Double-blind design

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical class I or II

排除标准

  • Patient refusal.
  • Pregnancy
  • Neuromuscular diseases (as myopathies, myasthenia gravies...)
  • Hematological diseases
  • Bleeding disorders
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • Sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m
  • Bilateral upper limb injury to be performed at the same procedure.

研究组 & 干预措施

Warm bupivacaine at (37°c)

Experimental

Warmed bupivacaine at body temperature will be administered

干预措施: Warm bupivacaine at (37°c) (Drug)

Bupivacaine at operating room temperature (23°c)

Active Comparator

Bupivacaine at temperature of 23°C will be administered

干预措施: Bupivacaine at operating room temperature (23°c) (Drug)

结局指标

主要结局

Time to onset of sensory block

时间窗: for 30 min following injection

defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)

次要结局

  • Heart rate(For 3 hours after the injection of local anesthetic)
  • Duration of sensory block(For 24 hours after the injection of local anesthetic)
  • Satisfaction Score(for 48 hrs after the injection of local anesthetic)
  • Blood pressure(For 3 hours after the injection of local anesthetic)
  • The severity of postoperative pain(For 24 hours after the injection of local anesthetic)
  • Time to onset of motor block(For 3 hours after the injection of local anesthetic)
  • oxygen saturation in the peripheral blood(For 3 hours after the injection of local anesthetic)
  • Time for first analgesic request(For 24 hours after the injection of local anesthetic)
  • Duration of motor block(For 24 hours after the injection of local anesthetic)
  • Total analgesics received(for 24 hrs after the injection of local anesthetic)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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