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临床试验/NCT06352255
NCT06352255已完成不适用

Analysis of Pain and Anxiety With Carpule vs Syringe in Digital Anesthesia of the Hallux

University of Seville2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2024年3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
264
试验地点
2
主要终点
Grade of Pain postinyection

研究概览

简要总结

INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.

OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.

METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.

Result: after the completion of the study CONCLUSIONS: After the completion of the study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

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

  • Subjects over 18 years of age
  • Both sexes
  • Participants must present nail pathology that requires surgical intervention.

排除标准

  • Systemic degenerative
  • Neuromuscular diseases
  • Pregnant or likely to be pregnant

结局指标

主要结局

Grade of Pain postinyection

时间窗: Immediately after the intervention

Analyze the pain using the VAS scale (Visual Analog Scale) caused during the anesthetic process. The lowest score on this scale is 0 (no pain) and the highest is 10 (maximum bearable pain).

次要结局

  • Anxiety before the intervention(Immediately before the intervention, since it is a scale that scores from 1 to 3 the degree of anxiety of the patient prior to the surgical intervention.)

研究者

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

ANA MARIA RAYO PEREZ

Principal Investigator

University of Seville

研究点 (2)

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