跳至主要内容
临床试验/NCT05209711
NCT05209711Unknown不适用

Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves

Mogilev Regional Clinical Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Сomplete sensory femoral nerve block

研究概览

简要总结

In modern anesthesiology, peripheral nerve blocks are performed using ultrasound control and electrical stimulation of peripheral nerves (PEN), or only ultrasound control or only EPN. The most effective methods are with the use of ultrasound control. Until now, the effectiveness of the femoral nerve blockade, performed only under ultrasound control without EPN, in comparison with the blockade of the femoral nerve performed under ultrasound control with EPN, has not been established.

There is no data on how the effectiveness of the blockade of the femoral nerve with small doses of lidocaine is influenced by the method of performing the blockade: under ultrasound control versus ultrasound control with electrostimulation of the nerve.

Research hypothesis: the blockade of the femoral nerve (7.5 ml 1%lidocaine -Minimum Effective Dose - previously established ) performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • indication requiring anesthesia maintenance;
  • patient's written consent about the type of anesthesia and possible complications of regional anesthesia

排除标准

  • patient's refusal of application for the proposed form of anesthesia;
  • patients younger than 18 years;
  • patients weighing less than 50 kg;
  • a physical status score of more than 3 determined by the American Society of --Anesthesiologists (ASA);
  • a history of allergic reactions to the drugs used;
  • coagulopathies;
  • infections of the skin at the injection site;
  • neurological or neuromuscular diseases;
  • severe liver diseases or kidney failures;
  • an inability to cooperate with the patient.

结局指标

主要结局

Сomplete sensory femoral nerve block

时间窗: The quality of sensory blocks was assessed after 45 minutes of administration of the sciatic nerve block. The evaluation of the block was carried out by an anesthesiologist who was not involved in the study, and was blinded to solution that had been]

The stimulus of the needle prick was applied to check the sensory block of thefemoral nerve. The assessment of skin sensitivity was carried out with the help of a similar scale: + +\\ indicating a complete sensory block; +\\ indicating a partial sensory block, a patient was unable to differentiate between the type of stimuli ; and -\\ indicating that the skin sensitivity was fully preserved.

次要结局

  • Сomplete motor femoral nerve block(The quality of motor blocks was assessed after 45 minutes of administration of the sciatic nerve block. The evaluation of the block was carried out by an anesthesiologist who was not involved in the study, and was blinded to solution that had been)

研究者

发起方
Mogilev Regional Clinical Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Valery Piacherski, Ph.D.

Chief of the Department of Anesthesiology and Intensive Care

Mogilev Regional Clinical Hospital

研究点 (2)

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