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临床试验/NCT05750264
NCT05750264进行中(未招募)2 期

Efficacy of Intravenous Ibuprofen in Multimodal Pain Management After Open Abdominal Hysterectomy: A Randomised Trial

Menoufia University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2023年3月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
152
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

The current research is designed to investigate the analgesic efficacy of intravenous ibuprofen on the postoperative analgesic requirements, pain intensity and other recovery parameters.

详细描述

The patients will be given general anaesthesia. Anaesthesia will be induced by propofol 1-2 mg/kg, and fentanyl 1-2 µg/kg. Endotracheal intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane in oxygen - air mixture. Transversus abdominis plane block will be performed at the end of the operation. A postoperative analgesic regimen according to group allocation will be started.

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)

入排标准

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

入选标准

  • American Society of anaesthesiologists physical status I to III.
  • Open abdominal hysterectomy operations

排除标准

  • History of gastrointestinal bleeding.
  • History of intracranial haemorrhage.
  • Pregnancy and lactation.
  • Taking angiotensin converting enzyme(ACE) inhibitors or anticoagulation drugs.
  • Asthmatic, hepatic,renal or heart failure.
  • Abnormal platelet count.

研究组 & 干预措施

ibuprofen group

Active Comparator

intravenous ibuprofen 800mg in 200 ml normal saline+IV paracetamol 1000mg+Transversus abdominis plane block

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Morphine consumption

时间窗: Postoperative up to 24 hours

mg

次要结局

  • Arterial oxygen saturation(Perioperative)
  • End tidal carbon dioxide(Perioperative)
  • Time of first ambulation(First postoperative 24 hours)
  • Duration of hospital stay(Postoperative up to 4 weeks)
  • Pain intensity(Postoperative up to 24 hours)
  • Anaesthesia recovery time(Perioperative)
  • Respiratory rate(Perioperative)
  • Heart rate(Perioperative)
  • Duration of post anaesthesia care unit stay(First postoperative 24 hours)
  • Mean arterial blood pressure(Perioperative)

研究者

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

Abd-Elazeem Abd-Elhameed Elbakry

Assistant professor

Menoufia University

研究点 (1)

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