跳至主要内容
临床试验/NCT03619538
NCT03619538已完成不适用

Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Estimate morphine consumption

研究概览

简要总结

This study analyses interest of iv nefopam in combination with paracetamol after major abdominal surgery because the effect of morphine-sparing is discussed when combined these agents.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Adult patient with a score ASA between I and III
  • Patient scheduled for elective major abdominal surgery (by laparotomy) for cancer or diverticulosis
  • Patient that signed the consent form

排除标准

  • - Patient treated in emergency situation
  • Patient with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
  • Patient that needs a surgery for restoration of continuity
  • Patient pregnant, breastfeeding, or during periods of genital activity using no contraception.
  • Patient with contraindications to nefopam, morphine, or paracetamol
  • Patient with chronic obstructive pulmonary disease, renal or severe hepatic impairment
  • Patient under analgesics treatment
  • Patient who participated in a clinical study in the previous 6 months.

研究组 & 干预措施

control group

Placebo Comparator

干预措施: saline solution (Other)

Nefopam group

Experimental

干预措施: Nefopam (Drug)

结局指标

主要结局

Estimate morphine consumption

时间窗: over 48 hours

mg

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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