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临床试验/NCT00956137
NCT00956137已完成不适用

A Randomised Controlled Trial of Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks.

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2009年5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
180
试验地点
2
主要终点
The success rate of dural puncture on the first needle insertion attempt.

研究概览

简要总结

Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many of the patients presenting for total joint arthroplasty. This is because of obesity, previous spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an appropriate site for needle insertion in spinal anesthesia, and that this results in a high success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia is extremely useful, especially in patients with poor-quality surface landmarks. However there are no published randomized controlled trials to date that compare the efficacy of the ultrasound-assisted technique with the traditional surface landmark-guided technique of spinal anesthesia.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Planned spinal anesthesia for elective lower limb surgery; and one or more of the following:
  • Body mass index ≥ 35 kgm-2
  • Scoliosis or other spinal deformity
  • Poorly palpable or impalpable spinous processes

排除标准

  • Patient refusal
  • Contra-indications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Inability to provide informed consent

结局指标

主要结局

The success rate of dural puncture on the first needle insertion attempt.

时间窗: within 2 hours prior to surgery

次要结局

  • number of needle insertions/re-directions; performance time; Pain score; Patient satisfaction; quality of ultrasound image; Correlation between palpation and ultrasound; Correlation between ultrasound and measured depth to i.t. space(within 2 hours prior to surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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