跳至主要内容
临床试验/NCT03377764
NCT03377764终止不适用

Can Anesthesia Trainees Effectively Use Ultrasound Imaging to Facilitate the Performance of Spinal Anesthesia in Patients With Poorly-palpable Surface Landmarks?

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
48
试验地点
1
主要终点
The rate of successful dural puncture on the first needle insertion attempt.

研究概览

简要总结

Anesthesia trainees can perform spinal anesthesia in patients who have poorly-palpable surface landmarks with fewer needle passes using an ultrasound-guided technique compared to the conventional surface landmark-guided technique.

详细描述

Neuraxial blockade has traditionally been accomplished using a surface landmark-guided technique, in which the approximate location of the neuraxial midline, lumbar interspinous and interlaminar spaces are determined based on palpation of the intercristal line and the tips of the spinous processes. It is not surprising, therefore, that the technical difficulty of neuraxial blockade (usually measured in terms of the number of needle passes required for success) correlates with the quality of palpable surface landmarks.

Reducing the technical difficulty of neuraxial blockade is desirable as multiple needle insertion attempts may increase the risk of complications such as post-dural puncture headache, paresthesiae, and epidural hematoma. Ultrasound (US) imaging of the spine can help in this regard by more precisely identifying landmarks, determining the intervertebral level, and measuring the depth to the epidural space. It has been shown to facilitate the performance of neuraxial block in the obstetric population, and our group has also demonstrated similar benefits in the older non-obstetric population. In a feasibility study of US-guided spinal anesthesia for total joint replacement surgery, achieved successful spinal anesthesia with a single needle insertion attempt in 84% of these patients, despite the fact that nearly half of them had poorly palpable surface landmarks.This compares well with large prospective cohort studies which report successful neuraxial blockade on the first needle insertion attempt in 61-64% of all patients. Investigators recently completed a randomized controlled trial in which 120 patients with difficult anatomical landmarks (defined as poorly palpable surface landmarks and a BMI>35 kgm-2, significant spinal deformity, or spinal surgery resulting in distortion or absence of surface landmarks) received spinal anesthesia performed by experienced anesthesiologists using either a conventional surface landmark-guided technique or an US-guided technique. There was a two-fold difference between the US-guided group and the control group in the first-attempt success rate (62% vs 32%, P<0.001), and the median number of needle passes required for success (6 vs 13, P=0.003).

The main limitation of all clinical studies conducted to date on US-guided neuraxial block is that ultrasound imaging was performed solely by experienced operators; although in two studies the neuraxial block itself (but not the ultrasound scan) was performed by trainees.

Investigators believe that the benefits of the US-guided technique can be realized when it is performed in its entirety by novices, e.g. anesthesia trainees. Investigators therefore designed this study to establish if novices are able to use the US-guided technique to facilitate the performance of spinal anesthesia in obese patients with poorly-palpable landmarks.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients presenting for elective total hip or knee replacement under spinal anesthesia who have poorly palpable or impalpable spinous processes
  • BMI ≥ 35 kgm-2

排除标准

  • Inability or refusal to provide informed consent,
  • Bleeding diathesis,
  • Allergy to local anesthetics
  • Contra-indication to spinal anesthesia

结局指标

主要结局

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

时间窗: 2012-2013

Insertion attempts are defined as complete withdrawal of the needle or introducer from the skin followed by re-insertion, and are distinguished from redirection attempts, which are defined as changes in needle trajectory that do not involve complete withdrawal of the needle from the skin. 1,2.14,15 This will be assessed by two blinded observers from an anonymized video recording of the operator's hands as they perform the spinal anesthetic.

次要结局

  • The total number of needle passes required for dural puncture.(2012-2013)
  • Block performance time(2012-2013)
  • Time taken to perform spinal anesthetic(2012-2013)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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