Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- VAS score (Visual analogue scale)
研究概览
简要总结
Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC
详细描述
Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Vortioxetine (VO) is a multimodal serotonergic antidepressant with a unique mechanism of action that is effective in treating neuropathic pain. The purpose of this study is evaluating the efficacy and tolerability of preoperative oral administration of Vortioxetine on postoperative pain control in patients undergoing 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
- None
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.
- •Adults (males and/or females) between the ages of 18-70 years old.
排除标准
- •Chronic pain other than cholelithiasis.
- •Patients who received analgesics or sedatives 24 h before scheduled surgery.
- •Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl <30ml/min)
- •Previous allergic response to vortioxetine.
- •Pregnancy and lactation
- •Patients with communication problems, cognitive dysfunction, or psychological disorders
- •Daily corticosteroid use
研究组 & 干预措施
Intervention arm
20 mg oral vortioxetine tablet 2 hours before the procedure
干预措施: Vortioxetine 20Mg Tab (Drug)
Control Arm
The patient will not be administered with any drug/placebo before the surgery
结局指标
主要结局
VAS score (Visual analogue scale)
时间窗: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Pain intensity: VAS score from 0 to 100 mm In which 0 means no pain, and 100 means the worst pain possible
次要结局
- Quality of life (QoL) after laparoscopic cholecystectomy (LC)(3 months)
- Time to analgesic request(24 hours)
研究者
Hoda Mohamed
Principal investigator
Future University in Egypt