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临床试验/NCT02271867
NCT02271867已完成4 期

Thermal Quantitative Sensory Testing as a Method to Semi-quantitatively Assess the Neurosensory Effects of 3 Local Anesthetic Solutions in an Interscalene Block

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2009年7月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
45
试验地点
1
主要终点
Presence of sensory block

研究概览

简要总结

Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible

排除标准

  • •contraindications for ISB
  • •diabetes mellitus
  • •peripheral neuropathy
  • •patients receiving chronic analgesic therapy
  • •contraindications for NSAID
  • •patients with an initial QST with abnormal values

研究组 & 干预措施

Levobupivacaine 0,5%

Active Comparator

Levobupivacaine 0,5% 15 ml once

干预措施: Interscalene block (Procedure)

Levobupivacaine 0,5% with epinephrine

Active Comparator

Levobupivacaine 0,5% with 1/200000 epinephrine 15 ml once

干预措施: Interscalene block (Procedure)

Ropivacaine 0,75%

Active Comparator

Ropivacaine 0,75% 15 ml once

干预措施: Interscalene block (Procedure)

结局指标

主要结局

Presence of sensory block

时间窗: 24 hours after intervention

次要结局

  • Block duration(24 hours after intervention)
  • Degree of sensory stimulus detection threshold variation from baseline values(24 hours after intervention)
  • Presence of motor block(24 hours after intervention)
  • Use of rescue medication(24 hours after intervention)

研究者

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

Ethisch Comité UZ Antwerpen

Thermal Quantitative Sensory Testing as a method to semi-quantitatively assess the neurosensory effects of 3 local anesthetic solutions in an interscalene block

University Hospital, Antwerp

研究点 (1)

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