跳至主要内容
临床试验/NCT04346758
NCT04346758已完成不适用

Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.

Attikon Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Time required to localize the lumbar plexus

研究概览

简要总结

A revised ultrasound-guided approach to the lumbar plexus is investigated as for efficacy and safety in elderly trauma patients undergoing operations of the lower extremeties.

详细描述

A modified ultrasound-guided Shamrock approach combined to nerve stimulation of the lumbar plexus is going to be investigated, in elderly trauma patients undergoing procedures of the lower extremities. The technique is going to be assessed as for its safety and its accuracy in localization of the plexus, by multiple measurements of the imaging time and needling time, In addition, efficacy and complications will be recorded and assessed during the immediate postoperative period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients undergoing orthopedic trauma operations of the lower extremeties
  • Age >70 years old

排除标准

  • Preexisting neuropathy of Lumbar plexus
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • Allergy to local anaesthetics
  • Prior surgery at the lumbar region

结局指标

主要结局

Time required to localize the lumbar plexus

时间窗: 10 minutes (from the begining of imaging procedure) (time in seconds to localize the plexus)

The time (in secondes) required of this modified Shamrock method to localize the lumbar plexus in the interpsoas compartment in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. Imaging time will be calculated (time to obtain appropriate imaging of the plexus) as well as needling time (time to obtain appropriate needle placement on the plexus)

Complications from lumbar plexus blockade

时间窗: 1 month

Safety of the modified Shamrock method of lumbar plexus blockade in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. All possible complications will be recorded (i.e. neurological complications, numbness, mobility disorder, haemmorhage, haematoma, e.t.c.)

次要结局

  • Postoperative pain(4 hours (visual analogue scale 0-10 at 4 hours postoperatively))

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

THEODOSIOS SARANTEAS

Associate Professor of Anesthesiology

Attikon Hospital

研究点 (1)

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