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临床试验/NCT01527812
NCT01527812已完成不适用

Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Operative Fixation of Fractured Neck of Femur

Cork University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia.

研究概览

简要总结

The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.

详细描述

Fractured neck of femur is a common cause of admission to hospital in elderly patients and requires operative fixation. The recommended anaesthetic technique for these cases is spinal anaesthesia, which is performed with the patient in lateral decubitus. Positioning the patient prior to administering spinal anaesthesia is the most painful manouvre due to the movement of the fractured bone.

Regional anaesthesia is effective in alleviating pain due to trauma, and it has the advantage of producing localized but complete pain relief (1). Femoral nerve blockade prior to positioning for spinal anaesthesia provides excellent pain relief and is a well tolerated procedure (2-5).

Using ultrasound guided femoral nerve block is a relative new method to improving the block success rate. It is widely used in our hospital. In a recent study Casati and al. showed a 42 % decrease of ED50% using ultrasound for localization of the femoral nerve (6). In a recent editorial by Brian D. Sites was mentioned that the positioning of the local anaesthetic in ultrasound guided blocks is unclear (7). We currently follow different patterns in relation to injection of the local anaesthetic solution around the femoral nerve. One of them is a circumferencial spread around the nerve. This, however, needs several needle passes which are likely to be painful for the patient. Another option is injecting the local anaesthetic on one side, above or below the nerve without changing the position of the tip of the needle, avoiding patient discomfort. Whether this results in a comparable quality of sensory block is unknown. The femoral nerve is separated in branches at this level and we assume that the spread of local anaesthetic may influence the quality and the distribution of the block. We propose to study the characteristics of femoral nerve block in relation to different patterns of local anaesthetic injection (circumferencial, inferior or superior).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Fractured neck of femur surgical fixation performed under spinal anaesthesia
  • ASA I to III

排除标准

  • Patient refusal
  • Coagulation disorders
  • Head injury or other associated injuries
  • Previous vascular surgery in the femoral area.
  • Loss of consciousness and signs of acute coronary syndrome
  • Mini-Mental Score < 25 (see appendix 3)
  • Allergy to lignocaine,
  • Skin lesions/infection at site of injection

结局指标

主要结局

Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia.

时间窗: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.

Independent blinded observer will assess the patient in the first 30 minutes, in every 5 minute. Sensory perception will be assess by using cold spray in the area of the terminal branch of femoral nerve. We will assess the pain on passive movement of the limb (elevating 30 degree) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the patient will be positioned for spinal anaesthesia. If the threshold isn't achieved by 30 minutes, the block will be classified as failure. Additional opioid medication and/or sedation will be administered.

次要结局

  • Sensory distribution of the nerve block.(The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.)
  • Number of needle passes(during performing the femoral nerve block)
  • Femoral nerve block onset time(In the first 30 minutes after the femoral nerve block)
  • Patient satisfaction(After the surgery in the recovery area before the patient will be discharged to the ward.)

研究者

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

Szilard Szucs

Clinical Tutor in Anaesthesia

Cork University Hospital

研究点 (1)

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