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临床试验/NCT04215276
NCT04215276已完成不适用

Comparison of Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

Indonesia University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Pain measurement during injection with VAS score

研究概览

简要总结

The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection.

详细描述

This was an experimental study on 70 subjects with 35 subjects treated with Valsalva maneuver and 35 subjects treated as control from January to April 2019. Research subjects were female who underwent brachytherapy for the first time with spinal anesthesia. The effectiveness in reducing pain was assessed by using Visual Analogue Scale (VAS) and patient movement during the surgery.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients underwent elective surgery using spinal anesthesia
  • patients who have not undergone spinal anesthesia before
  • Physical status ASA I or II
  • Signing informed consent

排除标准

  • have a spinal anesthesia history
  • contraindicated for spinal anesthesia
  • subjects who cannot do Valsalva to 30mmHg pressure for 20 seconds
  • have a allergic history to local anesthetics or opioid drugs

结局指标

主要结局

Pain measurement during injection with VAS score

时间窗: 30 seconds

Pain degree was measured with VAS score \[0 equals to no pain whereas 10 equals to the maximum pain\]

次要结局

  • Patient movement(30 seconds)

研究者

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

Alfan Mahdi Nugroho

Principal Investigator

Indonesia University

研究点 (2)

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