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临床试验/NCT05547659
NCT05547659已完成1 期

Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy

October 6 University2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
95
试验地点
2
主要终点
Postoperative visual analogue scale (VAS)

研究概览

简要总结

Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Patients undergoing laparoscopic cholecystectomy
  • Patients older than 18 years old

排除标准

  • Renal or hepatic or cardiac impairment patients
  • Patients with chronic pain history
  • Allergic patients after taking aspirin or other NSAIDs
  • patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding

研究组 & 干预措施

multimodal

Active Comparator

pregabalin/ acetaminophen/ celecoxib

干预措施: Pregabalin 150mg (Drug)

multimodal

Active Comparator

pregabalin/ acetaminophen/ celecoxib

干预措施: Acetaminophen 1 G Oral Tablet (Drug)

multimodal

Active Comparator

pregabalin/ acetaminophen/ celecoxib

干预措施: Celecoxib 400Mg Oral Capsule (Drug)

unimodal

Active Comparator

Pregabalin

干预措施: Pregabalin 150mg (Drug)

结局指标

主要结局

Postoperative visual analogue scale (VAS)

时间窗: 24 hour postoperative

The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.

Amount of post operative Needed opioid analgesia

时间窗: 24 hour postoperative

ampules of opioid analgesia needed after operation

次要结局

  • Type and amount of prescribed post operative non opioid analgesia(24 hour postoperative)

研究者

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

engy wahsh

head of clinical pharmacy unit

October 6 University

研究点 (2)

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