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临床试验/NCT04029662
NCT04029662已完成不适用

Comparison of Valsalva Maneuver and Control Technique in Reducing Pain Intensity During Spinal Needle Insertion

Indonesia University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Level of Pain Intensity

研究概览

简要总结

This study was aimed to observe the efficacy of Valsalva maneuver in reducing pain intensity during spinal needle insertion.

详细描述

Spinal anesthesia is one of the regional anesthesia techniques needed to provide motor, sensory, and autonomic blocks specifically for lower limbs by delivering local anesthetics into subarachnoid space. This technique is not difficult to perform and relatively inexpensive. However, spinal anesthesia may cause an intense pain during needle insertion. Valsalva maneuver is an attempt to force expiration by pushing a closed airway, such as covering nose or mouth. This maneuver can lead to anti-nociceptive stimulation and may decrease the pain. Thus, this study was aimed to observe the efficacy of Valsalva maneuver in reducing pain intensity during spinal needle insertion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Elective patients having spinal anesthesia
  • Patients with no previous history of spinal anesthesia
  • Patients with criteria of American Society of Anaesthesiologist (ASA) I-II
  • Patients willing to participate in the study and signing informed consent form

排除标准

  • Patients with contraindications of spinal anesthesia
  • Patients with difficulty in blowing 30 mmHg for 20 seconds
  • Patients having allergic reactions due to local anesthetics and opioid

研究组 & 干预措施

Group Control

No Intervention

Patients who undergo spinal anesthesia and perform nothing to reduce the pain intensity

Group Valsalva Maneuver

Experimental

Patients who undergo spinal anesthesia and perform Valsalva maneuver to reduce the pain intensity

干预措施: Valsalva Maneuver (Behavioral)

结局指标

主要结局

Level of Pain Intensity

时间窗: 15 minutes

Pain Measurement by Visual Analog Scale or Numeric Rating Scale with Range 1-10

次要结局

未报告次要终点

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 (1)

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