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临床试验/NCT04410588
NCT04410588Unknown2 期

Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
75
试验地点
1
主要终点
postoperative pain by visual analoge score

研究概览

简要总结

the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • All patients in the age of 18-60 year
  • Undergoing elective nasal endoscopic surgery

排除标准

  • Patients will also be excluded if any perioperative cardiovascular or respiratory event occurred which the anaesthetist with clinical responsibility for the patient thought would make the study intervention clinically unacceptable.
  • unsatisfactory preoperative peripheral arterial oxygen saturation.
  • Unsatisfactory preoperative hemoglobin level.
  • Neurological or psychiatric disease.

研究组 & 干预措施

levobupivacaine

Active Comparator

levobupivacaine for pain of nasal packing

干预措施: levobupivacaine (Drug)

fentanyl +levobupivacaine

Active Comparator

fentanyle with levobupivacaine for pain of nasal packing

干预措施: Fentanyl + Topical Levobupivacaine (Drug)

结局指标

主要结局

postoperative pain by visual analoge score

时间窗: 24 houres postoperative pain assessment

assessment of pain on removal of nasal packing after endoscopic nasal surgery by VAS score. The Visual Analogue Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum 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

Marwa mahmoud Abd El Rady

Principal Investigator

Assiut University

研究点 (1)

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