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临床试验/NCT07426679
NCT07426679招募中不适用

Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?-Protocol of a Randomised Controlled Study

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Successful first spinal block attempt

研究概览

简要总结

Neuraxial blockade is commonly performed using a manual palpation technique, but the procedure can be challenging, particularly in patients with high body mass index, pregnancy, or spinal deformities. Preprocedural ultrasound may improve identification of the optimal injection site, yet its use in clinical practice remains limited, partly due to a lack of structured training.

This multicentre randomised controlled trial investigates whether anaesthesiologists performing ultrasound-assisted spinal anaesthesia achieve better clinical outcomes and higher patient satisfaction compared with the traditional manual palpation technique. Both novice anaesthesia residents and more experienced anaesthesiologists are included.

Participants receive structured simulation-based training using either ultrasound-assisted or manual palpation techniques, following a mastery learning approach with predefined performance standards. After certification, participants perform spinal anaesthesia during elective lower limb surgery, with clinical performance assessed by senior anaesthesiologists.

The primary outcome is first-attempt success of spinal block. Secondary outcomes include number of attempts, needle redirections, time spent, need for assistance, and overall block success. Patient satisfaction and complications are assessed as tertiary outcomes.

This study aims to provide evidence on the clinical effects of structured training in ultrasound-assisted neuraxial access and to explore the role of prior clinical experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Physicians will be included using the following inclusion criteria:
  • Physicians working in anaesthesia
  • Opportunity to use the spinal block technique within 2 weeks of the training session.
  • Eligible patients will be those scheduled for elective lower limb surgery requiring spinal anaesthesia.

排除标准

  • Exclusion criteria: Patients under 18 years of age.

研究组 & 干预措施

Ultrasound-assisted spinal anaesthesia

Experimental

Participants will be trained using ultrasound to assist spinal anaesthesia

干预措施: Ultrasound-assisted spinal anaesthesia (Procedure)

Manual palpation technique for spinal anaesthesia

Active Comparator

Participants will be trained using standard methods of manual palpation technique for spinal anaesthesia

干预措施: Control group (Procedure)

结局指标

主要结局

Successful first spinal block attempt

时间窗: During spinal blocks

Single skin puncture without redirection and with backflow of cerebrospinal fluid

次要结局

  • Number of attempts(During block)
  • Number of redirections(During block)
  • Successful block for operation(During block)
  • Need for supervisor's verbal help(during block)
  • Need for supervisor's technical assistance(During block)
  • Time spent(During block)
  • Need for sedation during spinal anaesthesia placement(During block)
  • Additional intervention required intraoperatively- unexpected general anaesthesia(During block)
  • Additional intervention required intraoperatively- need for sedation(During block)
  • Expected difficult access(During block)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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