Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- VAS score
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 IP granisetron 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. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron 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
- Quadruple (Participant, Care Provider, Investigator, 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.
- •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 granisetron.
- •Pregnancy and lactation
- •Patients with communication problems, cognitive dysfunction, or psychological disorders
- •Daily corticosteroid use
研究组 & 干预措施
Control arm
2 ml IP normal saline (0.9 % NaCl)
干预措施: Normal saline (Other)
Intervention arm
2ml IP granisetron (1 mg/mL)
干预措施: Granisetron 1 Mg/mL Intravenous Solution (Drug)
结局指标
主要结局
VAS score
时间窗: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Pain intensity: VAS score
次要结局
- Time to analgesic request(24 hours)
- Quality of life (QoL) after laparoscopic cholecystectomy (LC)(3 months)
研究者
Hoda Mohamed
Teaching Assistant- Pharmacy Practice & Clinical Pharmacy
Future University in Egypt