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临床试验/NCT06038825
NCT06038825已完成不适用

The Effect of Topical Vibration on Injection Pain in Scalp Block

Diskapi Teaching and Research Hospital2 个研究点 分布在 2 个国家目标入组 56 人开始时间: 2023年6月1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
56
试验地点
2
主要终点
pain score (NRS)

研究概览

简要总结

In this study; it's aimed to reduce injection pain during the practice of scalp block, which is used as a method of anesthesia in patients who underwent awake craniotomy surgery. For this purpose, the investigators used topical vibration stimulation, which is non-invasive procedure.

详细描述

Scalp block is an analgesia technique frequently used in neurosurgical procedures. In this block, while providing adequate anesthesia for surgery, it also helps to preserve hemodynamics by inhibiting pain sensation. In this block, there is a certain degree of pain due to multiple injections. The transmission of pain sensation to the cortex is reduced by costimulating the receptors that transmit the pain sensation with vibration stimulus. In this study; it was aimed to investigate the effect of topical vibration on injection pain in participants who received sedoanalgesia with dexmedetomidine in bilateral scalp block practice.

In routine clinical practice, bilateral scalp block (local anesthetic injection into greater occipital, lesser occipital, supratrochlear, supraorbital, auriculotemporal, zygomaticotemporal nerves) is performed in participants who is sedated. While local anesthetic is injecting, vibration device (Aprilla brand, giving 6000 vibrations per minute) will be vibrated for 10 seconds and then local anesthetic will be injected. Meanwhile, participants' numerical pain scores (NRS) and hemodynamic parameters will be monitored.

In this study, the NRS scores and hemodynamic variables of the participants will be compared during the local anesthetic application of each 6 nerves bilaterally and during the injections of the nerves with and without the use of vibration.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between the ages of 18-75
  • ASA (American Society of Anesthesiologists) Scoring I-III
  • Cases in which scalp block will be applied

排除标准

  • ASA score IV
  • Uncooperative
  • Known allergy to any of the study drugs

结局指标

主要结局

pain score (NRS)

时间窗: during needling (injection) procedure

0 ; no pain,10; the worst pain ever possible

次要结局

  • Mean arterial pressure (mmHg)(baseline, during needling procedure, 1 min after needling)
  • Heart Rate (beat/min)(baseline, during needling procedure, 1 min after needling)

研究者

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

derya özkan

professor medical doctor

Diskapi Teaching and Research Hospital

研究点 (2)

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