跳至主要内容
临床试验/CTRI/2021/01/030758
CTRI/2021/01/030758已完成不适用

COMPARATIVE EVALUATION OF EFFICACY OF THREE DIFFERENT TECHNIQUES OF EPIDURAL CATHETER FIXATION: A PROSPECTIVE RANDOMISED STUDY

Vidarshna V1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月29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
150
试验地点
1
主要终点
To identify a simple, safe and effective method of fixing the epidural catheter.

研究概览

简要总结

Epidural catheter fixation is very important. The technique of securing the epidural catheter has a major bearing on the efficacy of epidural analgesia

Inward migration of the epidural catheter has been reported with intravascular, subdural or subarachnoid injection of repeat doses. Outward migration might lead to loss of analgesia and unsuccessful attempts to re-establish it. Many factors have been correlated with migration, but an appropriate fixation technique for the catheter should form the most practical way to prevent it. To identify a simple, safe, non-invasive and effective method of fixing the epidural catheter.

Group S - Standard dressing

Group T - Subcutaneous tunneling

Group L - Lock-it fixator device

Patient is followed for 24hrs and observed for analgesia adequacy and catheter migration.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients requiring post operative epidural analgesia.

排除标准

  • Contraindication to neuraxial blockade Pre-existing neurological disabilities Significant spinal deformities Unable to understand, express and communicate visual analog scores.

结局指标

主要结局

To identify a simple, safe and effective method of fixing the epidural catheter.

时间窗: During fixation | At end of surgery during shifting | During removal - at 24hrs

次要结局

  • Patient comfort(During catheter placement)

研究者

发起方
Vidarshna V
申办方类型
Other [Principle investigator ]

研究点 (1)

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