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临床试验/NCT04468685
NCT04468685已完成2 期

Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

National Hepatology & Tropical Medicine Research Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月15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
已完成
入组人数
50
试验地点
1
主要终点
change in postoperative pain between the two groups using visual analogue score (VAS)

研究概览

简要总结

Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. It has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. It possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP administration of ondansetron on pain management post LC.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are scheduled to undergo elective LC

排除标准

  • Patients undergoing chronic pain treatment
  • Previous allergic response to local anesthetics or 5-HT3 receptor antagonists
  • Patients who received analgesics or sedatives 24 h before scheduled surgery

研究组 & 干预措施

Ondansetron

Experimental

Ondansetron intraperitoneal in the gall bladder bed

干预措施: Ondansetron (Drug)

Saline

Placebo Comparator

Normal saline intraperitoneal in the gall bladder bed

干预措施: Normal saline (Drug)

结局指标

主要结局

change in postoperative pain between the two groups using visual analogue score (VAS)

时间窗: 24 hours

次要结局

未报告次要终点

研究者

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

Doaa abdelaziz

Lecturer of clinical pharmacy

National Hepatology & Tropical Medicine Research Institute

研究点 (1)

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