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临床试验/NCT04214574
NCT04214574已完成不适用

Real-Time Ultrasound-Guided Neuraxial Puncture in Elderly Patients: A Randomized Controlled Trial Comparing Between Paramedian Transverse and Parasagittal Oblique

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2020年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Incidence of successful Dural puncture on the first needle insertion attempt

研究概览

简要总结

In this prospective randomized observational study, investigators aim to compare the efficacy and procedural outcomes of real-time ultrasound guided parasagittal oblique (RTU-PO) and real-time ultrasound guided paramedian transverse (RTU-PT) approaches in elderly patients undergoing elective surgery under spinal anesthesia.

详细描述

Background: Since its first introduction in 1898 by Bier, Spinal anesthesia has been performed using the anatomical landmark guided approach. Despite being useful, the landmark technique doesn't take into account anatomical variations, spine abnormalities or age-related changes in the lumbar spine as seen in elderly, obese or pregnant patients and thus can lead to incorrect identification of a certain interspace. Neuraxial ultrasonography has been introduced as a technique to allow the operator to preview spinal anatomy, identify the midline, determine the interspace and guide the needle insertion site and trajectory. It was found to be a feasible and promising technique that can result in successful cerebrospinal fluid acquisition where other methods have failed. While pre-procedural Ultrasound has been used by many studies to identify the right epidural or subarachnoid spaces and have an idea about the angle of needle insertion, it remains a blind technique. Real-time ultrasound guided technique was found to improve the limitations of the pre-puncture ultrasound guided techniques by direct, real-time visualization of the needle trajectory. In spinal anesthesia, a midline approach has been the most common technique used for needle insertion. However, this approach is often technically difficult in the geriatric population because of poorly palpable surface landmarks, lumbar scoliosis, marked thoracic kyphosis, degenerative changes and inability to flex the lumbar spine in the sitting position. While the parasagittal oblique approach tends to provide a better sonographic window into the vertebral canal than the midline approach, it is still not evident whether it will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the paramedian transverse and parasagittal oblique approaches in the performance of real time ultrasound guided spinal anesthesia.

Specific Aim: The aim of this study is to find out the optimal approach to perform spinal anesthesia under real time ultrasound guidance in the elderly population. Thus, investigators will compare real time ultrasound-guided paramedian approach using parasagittal oblique view with real time ultrasound guided paramedian approach using the paramedian transverse median view. The aim is thus to adopt a real time ultrasound guided technique that will result in an easier access to the subarachnoid space in patients with difficult anatomy and results in better patient satisfaction and less discomfort.

Methodology and analysis: In a prospective randomized observational study, 84 patients scheduled for surgery amenable to spinal anesthesia, aged more than 65 years, with American Society of Anesthesiologists physical status 1 to 3 will be assigned to receive spinal anesthesia to one of two treatment groups: real time ultrasound-guided parasagittal oblique technique (group RTU-PO) or Real time ultrasound-guided paramedian transverse technique (group RTU-T). Ultrasonography of the lumbar spine and Real time spinal blockade will be performed by the experienced anesthesiologist. Patients in both groups will have an ultrasound scan of the lumbar spine to measure the depth of the dura, to specify and guide the needle insertion site and trajectory. The primary outcome is the rate of successful dural puncture on the first needle insertion attempt under real time ultrasound guidance. Normally distributed data will be summarized as mean ± SD and nonnormally distributed data will be summarized as median [interquartile range].

Significance: Investigators believe that real time US-guided technique is a superior modality of performance of spinal anesthesia. However, investigators would like to evaluate which approach will be better for the acquisition of cerebrospinal fluid in elderly patients. Investigators think that this study would have an impact on current practice in term of introducing real time ultrasound guided technique into everyday practice and determining the best approach to perform a successful neuraxial block in a patient with a suspected difficult back.

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
Double (Participant, Outcomes Assessor)

盲法说明

Due to the nature of the study, blinding of the anesthesiologist was not possible

入排标准

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

入选标准

  • Patients aging above 65 years
  • American Society of Anesthesiologists physical status 1 to 3
  • Can give informed consent
  • Scheduled for elective surgery

排除标准

  • Inability to sit or to give consent
  • Patients with severe cardiopulmonary diseases
  • Previous back surgery or spinal congenital abnormalities
  • Bleeding diathesis
  • Anticoagulants or antiplatelets except aspirin
  • Local anesthesia allergy

结局指标

主要结局

Incidence of successful Dural puncture on the first needle insertion attempt

时间窗: At the begining of the procedure (during the needle insertion)

Successful needle insertion on the first attempt (Yes/No)

次要结局

  • Procedural time(During the procedure)
  • Number of separate skin punctures(During the procedure)
  • Incidence of success of spinal anesthesia(During the procedure)
  • Time to identify posterior complex on ultrasound(During the procedure)
  • Time to perform spinal anesthesia(During the procedure)
  • Depth of the posterior complex(During the procedure)
  • Number of spinal levels attempted(During the procedure)
  • Rate of satisfaction(After the procedure)
  • Rate of complications, if present(During the procedure)
  • Number of redirections(During the procedure)
  • Number of needle passes(During the procedure)
  • Rate of complications(During the procedure)

研究者

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

Marwan Rizk

Principal Investigator

American University of Beirut Medical Center

研究点 (1)

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