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临床试验/NCT03335462
NCT03335462已完成不适用

The Spread of Paravertebral Injections in the Lumbar Plexus Area and Associated Risk Factors to Adjacent Organs: a CT Scan Based Report

Makassed General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Injection spread

研究概览

简要总结

Lumbar paravertebral block (LPB) has been used for anesthesia in different settings such as in varicocelectomy and inguinal hernia repair in adults and pediatrics. Different studies considered LPB as an alternative to general and spinal anesthesia when contraindications exist, especially in elderly patients. However, the results obtained when using LPB are controversial in terms of number of injections performed and the success rates.

详细描述

Patients scheduled for hernia repair who will agree to undergo different number of paravertebral injections in the thoraco-lumbar plexus area under CT guidance.

While the patient is in lateral decubitis position, LPB injections will be made using a 100 mm 22 G nerve stimulator needle (Stimuplex, B.Braun, Melsungen, Germany). The site of injection is determined by manual palpation. The number of injections ranges from one to five and the level of injections ranges from T11 to L3.

The needle is penetrated perpendicular to the skin using the following nerve stimulator settings: 5mA, 9V and 2Hz. The stimulating needle is gently manipulated into a position to allow an adequate muscular response with a stimulating current of 0.4-0.8 mA. At this point, 4-5 ml of the contrast (Telebrix 35, 350 mg/ml, Roissy CDG Cedex, France) is injected. The patients will receive the same amount of contrast, despite the different number of injections. The needles are kept in their position and afterwards followed by CT scan.

A radiologist who is blind to the study will interpret the radiological results and document the level at which the needle tip is found, the distance from the kidney and the spread of the injected contrast. In order to ensure patient's safety, different measures will be taken to keep the radiation as low as reasonably achievable.

Following the radiological practice, patients will be transferred to the operating room to undergo inguinal herniorrhaphy, and will not followed for the purpose of this study.

研究设计

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

入排标准

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

入选标准

  • Older than 18 years
  • Scheduled for hernia repair

排除标准

  • with coagulation disorders,
  • with infection at the injection site,
  • with allergy to contrast
  • receiving opioids

研究组 & 干预措施

Paravertebral injections

Experimental

Lumbar paravertebral injections containing contrast will be performed. The needles are kept in their position and afterwards followed by CT scan.

干预措施: Paravertebral injections (Other)

Paravertebral injections

Experimental

Lumbar paravertebral injections containing contrast will be performed. The needles are kept in their position and afterwards followed by CT scan.

干预措施: CT scan (Other)

结局指标

主要结局

Injection spread

时间窗: 5 minutes after the procedure

Demonstrate spread of injected material in the lumbar plexus area according to different number of injections confirmed by CT guidance

次要结局

  • Distance between injections and kidney(5 minutes after the procedure)

研究者

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

Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Makassed General Hospital

研究点 (1)

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