跳至主要内容
临床试验/CTRI/2014/09/004963
CTRI/2014/09/004963招募中不适用

Comparison of APAD vs Loss of resistance technique for localization of epidural space

Rajiv Gandhi Cancer Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年12月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Successful catheter placement in epidural space is primary outcome confirmed by below mentioned tests 1:Epidural pressure waveform confirmation for proper catheter placement has 100% specificity and positive predictive value and sensitivity of 80%.

研究概览

简要总结

This is aprospective randomized single blinded control trial , comparing  APADlocalization of epidural space with loss of resistance technique . Primary  aimof this study is  to locate epiduralspace by using  any one of the technique.Secondary  Objectives were to find the correlationbetween sonographic depth and procedural depth ,to record the time taken toperform individual technique and to assess the number of patients developingadverse event or complications in terms of dural puncture, nerve injury, PDPH .In thisstudy randomization was done using computer generated randomization ,andsequentially numbered  sealed  envelopes were allocated to patients .thenpatients were explained  about thetechnique with complete explanation about the benefits and drawbacks  of technique in their own language, once theyagreed , one of the investigator will perform ultrasound of spine and mark thespace ,and gives its measurement of epidural depth to outcome assessor . nowthe other investigator will perform procedure for epidural catheter placementas per the group allocated in sealed envelop ,now  outcome assessor will record the time timetaken to locate the epidural space, number of space tried , redirection ofneedle ,success of technique , placement of catheter any complications as per Performaand finally the VAS score given by patient.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA : I-III Pelvic, perineal ,lowerlimb or abdominal surgery.

排除标准

  • Localsite infection Patient unwillingness Any coagulopathy Spine abnormality/ surgery Obesity (BMI>29).

结局指标

主要结局

Successful catheter placement in epidural space is primary outcome confirmed by below mentioned tests 1:Epidural pressure waveform confirmation for proper catheter placement has 100% specificity and positive predictive value and sensitivity of 80%.

时间窗: not applicable

2:clinical confirmations using segmental field block by injecting local anesthetic through catheter and assessment using pin prick method after 5 minutes.

时间窗: not applicable

次要结局

  • Less discomfort to patient while giving position during procedure and lesser expected complications(not applicable)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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