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临床试验/CTRI/2018/02/012133
CTRI/2018/02/012133已完成不适用

Efficacy Of Pre-Procedural Ultrasound Of Lumbar Spine In Improving The Procedural Skill For Subarachnoid Block

Department Of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
procedural success in first needle pass

研究概览

简要总结

Spinalanaesthesia is one of the commonest procedures performed, and one of the firstskills to be acquired by an anaesthesiologist. It requires considerable skill, and demands a precise and totalunderstanding of regional anatomic relationships.  Acquiring adequate knowledge of the anatomyand orientation of central neuraxis, for performance of a successful block, isstill largely based on the “blind†landmark based procedure.  Radiological examination and simulation basedtraining techniques have been employed successfully, to better aid the teachingprocess.

In recent times, Ultrasonography has shedlight in various aspects in clinical anaesthesia, and has proven to be a usefultool for point of care procedures. Pertaining to central neuraxial blockade, USG guided procedures havebeen proven to identify and navigate the difficult anatomy, butbecause the procedure is time taking and there pose some difficulty inobtaining clear images, it is not routinely used in clinical practise.  However in a setting where practise makesperfect, to include its application as a teaching tool for the normal anatomy,may prove to improve the technique of lumbar puncture for spinal anaesthesia innormal as well as difficult anatomy, thereby reducing the distress experiencedby the patient with multiple attempts at spinal anaesthesia, also reducingincidence of associated complications (e.g hematoma, post dural punctureheadache) .  This study isdesigned to evaluate if a preprocedural ultrasonographic examination of the lumbarspine, improves the performance of lumbar puncture for spinal anaesthesia.

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
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I and II.

排除标准

  • patient refusal 2) Contraindication for spinal anaesthesia – infection at site, coagulopathy, allergy to local anaesthetics 3) Spinal Deformity 4) BMI>35, Pregnancy 5) Previous Spine Surgery 6) Lower Limb Fractures.

结局指标

主要结局

procedural success in first needle pass

时间窗: procedural success in first needle pass

次要结局

  • number of needle passes(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)
  • The number of attempts defined as the number of times the spinal needle is withdrawn from the skin and reinserted(defined as the number of times the spinal needle is withdrawn from the skin and reinserted)
  • The time taken to detect CSF(time from first needle insertion till CSF detection)

研究者

发起方
Department Of Anaesthesiology
申办方类型
Private medical college

研究点 (1)

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