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临床试验/NCT03790163
NCT03790163Unknown不适用

The Influence of Different Degrees of Levobupivacaine Temperature on Spinal Anesthesia in Orthopedic Surgeries: Prospective Randomized Study

Mansoura University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年1月15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
入组人数
120
试验地点
1
主要终点
Time to onset of sensory block

研究概览

简要总结

This study will be conducted to evaluate the effect of different temperature on the spinal anesthesia characteristics and incidence of complications

详细描述

Regional anesthesia techniques are also superior to systemic opioids agents with regard the analgesic profile and adverse effects .Spinal anesthesia is the most commonly used technique due to its unmatchable reliability,simplicity and cost-effectiveness. It provides a fast and effective onset of sensory and motor block, excellent muscle relaxation and prolonged postoperative analgesia .

Bupivacaine is commonly used local anesthetics because of its long duration of action and combined motor and sensory blockade. However, it has many drawbacks .It has a high propensity to cause hypotension and bradycardia. There is also cardiac toxicity.Levobupivacaine is an attractive alternative to bupivacaine because of the lower affinity for cardiac sodium channels and reducing the risk of cardiac toxicity.Moreover ,the isobaric levobupivacaine had more stability in cerebrospinal fluid and thus lead to more predictable drug spread, decreasing the incidence of hypotension and bradycardia. But its main disadvantage is the delayed onset .

A number of strategies have been used to hasten the onset of local anesthesia .The addition of fentanyl mixtures of local anesthetics and alkalization of the local anesthetics all shorten the onset time of sensory block. Recently the warming of the anesthetic agents (namely, lidocaine and bupivacaine) to 37° C hastens the sensory block in various surgical settings .

Up till now there is no study suggestive of any appropriate degree of temperature as adjuvant .Hence the present study will be conducted to evaluate the effect of different temperature on spinal anesthesia characteristics and the incidence its complication

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(participant ,care provider)

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA-I or II

排除标准

  • patient refusal; Any known hypersensitivity or contraindication to levobupivacaine pregnancy bleeding disorders local skin infections. Sepsis at the site of injection Coagulation abnormality Psychiatric disorders

研究组 & 干预措施

levobupivacaine at ( 23˚C)

Placebo Comparator

Levobupivacine hydrochloride at ( 23˚C) will be received 3.5 ml levobupivacaine at the operating room temperature 23˚C will be administered

干预措施: Levobupivacaine (Drug)

Warm levobupivacaine at (30˚C)

Active Comparator

Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (30˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia

干预措施: Levobupivacaine (Drug)

Warm levobupivacaine at (37˚C)

Active Comparator

Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (37˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia

干预措施: Levobupivacaine (Drug)

结局指标

主要结局

Time to onset of sensory block

时间窗: For 10 minutes following the spinal anesthesia

Defined as the time interval between the end of spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1)

次要结局

  • Time to the onset of motor block(For 10 minutes following the injection of spinal anesthesia)
  • Duration of sensory block(For 24 hours after the spinal anesthesia)
  • Duration of motor block(For 24 hours after the spinal anesthesia)
  • Post spinal shivering(for 24 hours after spinal anesthesia)

研究者

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

Abdelraouf Elsharkawy

Lecturer of anesthesia and surgical intensive care

Mansoura University Hospital

研究点 (1)

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