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临床试验/NCT06372691
NCT06372691已完成不适用

How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block;Is It Injection Subparaneural, Interneural?

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 92 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Onset Time

研究概览

简要总结

The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks.

详细描述

The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) III or IV risk group patients, 18 years of age or older, who will undergoing foot, ankle, or toe amputation.

Supparaneural injection (Group S) and interneural injection method (Group I) will the two research groups to which patients were randomly allocated.

Every 5 minutes following LA injection, an investigator who will blind to randomization will assess the sensory and motor blockage in the operated foot. The study will documented the operative time, block characteristics, such as the duration of block administration, sensory and motor block start and regression times, the time of extra analgesic required, and the occurrence of complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 18 years and over
  • Planned foot, ankle or toe amputation
  • ASA III-IV risk group
  • Patients who agreed to be included in the study

排除标准

  • People with neurological and psychiatric diseases
  • Using opioids or another analgesic for chronic pain
  • Allergic to local anesthetics
  • Pregnant or breastfeeding
  • Those with infection or sepsis in the application area
  • Patients who did not agree to be included in the study

结局指标

主要结局

Onset Time

时间窗: Time from the moment the block is made to the moment it starts, within the first half hour

Onset time will be defined as the moment when it is determined that the block is successful.

次要结局

  • Need for Multiple Injections Owing to Insufficient Anesthesia(Within 24 hours)
  • Additional Rescue Analgesic(Within 24 hours)
  • Block Execution Times(1-10 minutes)
  • Hemodynamic Effects Of The Block(0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes)
  • Regression Time Of Sensory and Motor Block(Within 24 hours)
  • Total Block Times(Within 24 hours)
  • Adverse Effects to Anesthesia(During the block period, within 24 hours)
  • Effects Of The Block On Heart Rate(0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes)
  • Effects Of The Block On Peripheral Pulse Oximetry(0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes)

研究者

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

semih başkan

Doç. Prof. Dr.

Ankara City Hospital Bilkent

研究点 (2)

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