Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy
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
- 否
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
Ondansetron intraperitoneal in the gall bladder bed
干预措施: Ondansetron (Drug)
Saline
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
Doaa abdelaziz
Lecturer of clinical pharmacy
National Hepatology & Tropical Medicine Research Institute
