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临床试验/CTRI/2021/03/032333
CTRI/2021/03/032333已完成4 期

COMPARISON OF EASE OF PROCEDURE AND SUCCESSRATE IN LUMBAR EPIDURAL ANAESTHESIA USING PRE-PROCEDURAL ULTRASOUND MARKING AND MANUALPALPATION TECHNIQUE IN KNEE ARTHROPLASTYPATIENTS

SAKRA WORLD HOSPITAL1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
144
试验地点
1
主要终点
1) Ease of epidural insertion as assessed by

研究概览

简要总结

Combined spinal epidural anaesthesia is the preferred choice for anaesthesia in knee arthroplasty patients. Lumbar neuraxial procedures are typically performed via a blind surface landmark and palpation technique. The success depends on good knowledge of anatomy and skills due to its complexity. Patient factors such as obesity, abnormal spinal anatomy or previous spine surgeries result in increased failure rate of neuraxial blockade. The intercristal line/ Tuffiers line determined by palpation may not be a reliable landmark for fourth and fifth lumbar interspace in neuraxial anaesthesia. Lumbar spinous process increases significantly in both length and width with ageing, which makes epidural anaesthesia technique challenging through midline in geriatric population in whom majority of knee replacement surgeries are done. Neuraxial ultrasonography in epidural space identification is a recent development and has shown to improve the success rate of neuraxial blockade and can reduce the risk of failed or traumatic lumbar punctures and epidural catheterizations. The use of preprocedural ultrasound has been shown to increase first pass success rate in thoracic epidural catheter insertion and spinal anaesthesia in patients with difficult surface landmarks. Therefore, this prospective, randomised study has been designed to assess the ease of insertion and its success rate after identification of the relevant landmarks using ultrasound as compared to traditional palpation of bony landmarks.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Adult’s patients of ASA 1 and 2 between 50-70 years coming for knee arthroplasty.

排除标准

  • •No consent from the patient’s caregiver/ patients or attender’s refusal.
  • •Lower limb Neuropathy in preoperative evaluation.
  • •History of lower back pain.
  • •Coagulation disorders
  • •Hemodynamic instability in perioperative period.
  • •Previous history of spine surgeries
  • •History of post-Dural puncture headaches.
  • •Allergy to local anaesthesia drugs (Lignocaine and Bupivacaine).

结局指标

主要结局

1) Ease of epidural insertion as assessed by

时间窗: after epidural cathetrisation

次要结局

  • 1. Comparison of pre-procedural epidural length determined by ultrasound with actual length identified by loss of resistance technique.(2. Comparison of comfort level felt by patient during epidural catheterization procedure.)

研究者

发起方
SAKRA WORLD HOSPITAL
申办方类型
Private hospital/clinic

研究点 (1)

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