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临床试验/NCT04294953
NCT04294953Unknown2 期

Efficacy of Perioperative Duloxetine as a Part of Multimodal Analgesia in Laparoscopic Colorectal Cancer Surgery

Assiut University0 个研究点目标入组 60 人开始时间: 2020年3月1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
60
主要终点
morphine consumption

研究概览

简要总结

Our aim will be to evaluate the efficacy of perioperative Duloxetine in decreasing acute postoperative pain after laparoscopic colorectal cancer surgery and its role in reducing postoperative morphine requirements

详细描述

Abdominal surgery is usually associated with severe; wide spread post-operative pain. The greater propensity for pain and opioid-related side effects are likely contributing factors for poor postsurgical recovery, and it often results in significant pain and slow recovery. Although Opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. Multimodal analgesia is advocated for perioperative pain management to reduce opioid use and its associated adverse effects. Multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia.Therefore, lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds.Serotonin and norepinephrine are involved in the modulation of endogenous analgesic mechanisms via descending inhibitory pain pathways in the brain and spinal cord. An increase in serotonin and norepinephrine may increase inhibition of nociceptive input and improve pain relief.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for the treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions. There several reasons why duloxetine might improve postsurgical quality of recovery. First, systemic Duloxetine seems to have perioperative analgesic effects. In addition, as a serotonin-norepinephrine reuptake inhibitor, it is possible that the drug may prevent transient emotional problems that are common during the perioperative period. Lastly, the combination of less pain and better emotional status can result in better physical independence scores after surgery.

The main objective of the current study is to examine the effect of perioperative Duloxetine on postoperative pain after laparoscopic colorectal surgery.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III
  • aged 18-65 years and scheduled for laparoscopic colorectal surgery for cancer colon

排除标准

  • unable to express their pain or patient refusal.
  • allergy to the study drug
  • an abnormal liver or renal function tests
  • a chronic opioid abuser(> 3 mo), being on chronic gabapentin or pregabalin(> 3 mo)
  • antidepressant drugs, patients with psychiatric disorders
  • Pregnant females

研究组 & 干预措施

Group (I) (D) : (Duloxetine group)

Active Comparator

干预措施: Duloxetine (Drug)

Group (II) (P): (placebo group)

Placebo Comparator

干预措施: Placebo oral tablet (Drug)

结局指标

主要结局

morphine consumption

时间窗: 48 hours postoperative

total morphine consumption(mg) in 48 hours if VAS score( Visual Analog Scale ) more than 3. score from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable

次要结局

  • pain scores(48 hours postoperative)
  • first request of analgesia(48 hours postoperative)
  • Postoperative sedation(48 hours postoperative)
  • Postoperative patient satisfaction(48 hours postoperative)

研究者

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

Mirna Ismail

principal investigator

Assiut University

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