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临床试验/NCT03134391
NCT03134391已完成不适用

Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection

Indonesia University1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Vital signs

研究概览

简要总结

This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from spinal injection

详细描述

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Vapocoolant spray group and eutectic mixture local anesthetics (EMLA) group). Intravenous (IV) cannulae with Ringer Acetate fluid, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room. Vital signs were recorded. Patients were positioned in sitting position and were instructed to flex their head and bend their back. Identification of intervertebral space L4-5 were performed. Asepsis and antisepsis procedure were performed. The Vapocoolant spray group received vapocoolant spray at a distance of 10 cm for 2 seconds and we waited for 10 seconds. The EMLA group received EMLA cream which consisted of 2.5% lidocaine and 2.5 % prilocaine in 2 ml of water/oil emulsion and then they received tegaderm as the dressing for 45-60 minutes before the cream was wiped off. Spinal injection using 27G needle were performed after the intervention to each groups. Needle bevels were aligned parallel to dura fibres. Patients' visual analog score (VAS) and movements were recorded. Evaluation was only done in the first injection attempt, and was followed until the depth of the needle was around 5 mm. After the injection was successfully performed, patients' position were changed into supine position. Evaluation and recording were performed by person who was blinded from the intervention. Vital signs were recorded for every 3 minutes in the first 15 minutes, and then every 5 minutes until the end of the procedure.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • woman aged >18 years old
  • American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo one-day care elective surgery at operating room in spinal anesthesia
  • patients who were planned to undergo brachytherapy

排除标准

  • Subjects with history of allergy to anesthetic agents
  • unstable hemodynamic
  • history of active psychotropic drug consumption
  • spinal anesthesia contraindications such as local infection, severe coagulopathy, severe hypovolemia, or increased intracranial pressure

研究组 & 干预措施

vapocoolant spray

Active Comparator

Subjects received Vapocoolant spray before spinal anesthesia

干预措施: Vapocoolant spray, EMLA (Drug)

EMLA

Active Comparator

Subjects received EMLA before spinal anesthesia

干预措施: Vapocoolant spray, EMLA (Drug)

结局指标

主要结局

Vital signs

时间窗: day 1

Vital signs for measuring pain indirectly

VAS

时间窗: Day 1

Visual Analog Scale for measuring pain

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

Riyadh Firdaus

Anesthesiologist Consultant

Indonesia University

研究点 (1)

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