Intraperitoneal ondansetron for postoperative analgesia in laparoscopic/robotic cholecystectomy : a double-blinded, randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy in pain relief from baseline to 12, and 24 hours post-operatively in the study population
研究概览
简要总结
Laparoscopic/robotic cholecystectomy is a frequently performed surgery for various gallbladder conditions, particularly gallstones. It is considered the standard technique for addressing benign biliary diseases. However, managing pain post-surgery presents a significant challenge due to its multifaceted nature. Local irritation caused by carbon dioxide intraperitoneal administration during the procedure, coupled with increased intra-abdominal pressure, contributes to postoperative pain.
Traditionally, opioids have been the go-to option for postoperative pain relief, despite their side effects like vomiting and respiratory depression. To address this, multimodal pain management has become popular to lower opioid doses and side effects.
Recent studies suggests that 5-HT3 antagonists, which impact serotonin, may have anti-inflammatory and pain-relieving properties. These drugs act on serotonin receptors to alleviate pain and may also bind to opioid receptors, acting as opioid-like pain relievers. Ondansetron, a 5-HT3 antagonist, might also block sodium channels, further aiding its pain-relieving effects. This suggests that 5-HT3 antagonists could be a promising new class of local anesthetics.
However, there have been a very few studies reporting the efficacy of ondansetron in alleviating post-laparoscopic & robotic cholecystectomy pain. Hence , in the present study we aim to conduct a prospective randomised controlled trail to assess the impact of intraperitoneal ondansetron administration as an adjunct to intravenous acetaminophen for postoperative pain management in patients undergoing laparoscopic & robotic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients more than 18 years planned for laparoscopic and robotic cholecystectomy.
排除标准
- •1.Patients who have liver or renal dysfunction.
- •2.Patients who have chronic pain other than symptomatic cholelithiasis.
- •3.Patients who have history of daily intake of corticosteroids or a history of allergy to any of the study drugs.
- •4.Patients with communication problems, cognitive dysfunction, or psychological disorders.
- •5.Patients who received analgesics or sedatives 24 h before a scheduled surgery.
- •6.All pregnant/lactating females 7.Patients undergoing concomitant surgeries 8.Minimally invasive procedure converted to open procedure.
结局指标
主要结局
To evaluate the efficacy in pain relief from baseline to 12, and 24 hours post-operatively in the study population
时间窗: To evaluate the efficacy in pain relief from baseline to 12, and 24 hours post-operatively in the study population
次要结局
- To compare the differences between study groups in Time to first rescue analgesic request(Cumulative consumption of rescue analgesic postoperative period till discharge.)
研究者
Mohd Sharib Wahaj
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) , Pondicherry