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临床试验/NCT02171975
NCT02171975已完成不适用

A Comparison of Conventional Landmark Guided Midline Versus Pre-procedure Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

Cork University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2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
100
试验地点
1
主要终点
Number of passes

研究概览

简要总结

Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The investigators hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinals reduces the number of passes required to achieve enter the subarachnoid space when compared to the conventional landmark-guided midline approach.

详细描述

Spinal anesthesia is widely performed using a surface landmark based 'blind' technique. Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma.

Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia has to date been limited to case series and case reports. Its use may be limited by the requirement for wide bore needles and the technical difficulties associated with simultaneous ultrasound scanning and needle advancement. The use of pre-procedural ultrasound has been shown to increase the first pass success rate for spinal anesthesia only in patients with difficult surface anatomic landmarks.No technique has been shown to improve the success rate of dural puncture when applied routinely to all patients.

Studies on pre-procedural ultrasound-guided spinal techniques are limited to a midline approach using a transverse median view (TM). The parasagittal oblique (PSO) view consistently offers better ultrasound view of the neuraxis compared to TM views. However no studies have been conducted to assess whether these superior PSO views translate into easier paramedian needle insertion.

We hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinal technique results in less number of passes required to enter the subarachnoid space when compared to the conventional landmark based midline approach.

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
Single (Participant)

入排标准

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

入选标准

  • all consented patients scheduled to undergo elective total knee or total hip arthroplasty under spinal anesthesia were included in the study.

排除标准

  • Patients with contraindications to spinal anesthesia (allergy to local anesthetic, coagulopathy, local infection and indeterminate neurological disease) were excluded from the study.

结局指标

主要结局

Number of passes

时间窗: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic

The number of passes, defined as the number of forward advancements of the spinal needle in a given interspinous space (i.e. withdrawal and redirection of spinal needle without exiting the skin)

次要结局

  • Time for identifying landmarks(Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete)
  • Time taken for performing spinal anesthetic(Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic)
  • Incidence of radicular pain(Up to 24 hours after administration of spinal anaesthetic)
  • Number of spinal needle insertion attempts(Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic)
  • Blood in spinal needle(Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic)
  • Presence of paresthesia(Up to 24 hours after administration of spinal anaesthetic)
  • Grading of palpated landmarks(Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete)
  • Peri-procedural VAS scores of pain at injection site(up to 30 minutes following spinal anaesthetic injection and prior to sedation)
  • peri-procedural discomfort scores(up to 30 minutes following spinal anaesthetic injection and prior to sedation)
  • Level of block(15 minutes after spinal anaesthetic injection)

研究者

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

Karthikeyan Kallidaikurichi Srinivasan

Specialist Registrar,Anaesthetics,Cork University Hospital

Cork University Hospital

研究点 (1)

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