Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Numeric rating scales (NRS) score with 24 hours after the surgery
研究概览
简要总结
The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets' oral administration on postoperative pain and rehabilitation after laparoscopic radical gastrectomy for patients with gastric cancer.
详细描述
Postoperative pain attracts the attention of surgeons, and optimal postoperative pain management contributes to reducing complications and accelerating postoperative rehabilitation. Traditionally, the opioids were used for postoperative pain control. However, the opioids may increase the time to recover bowel function and lead to postoperative ileus. Multimodal analgesia is recommended in recent years, but studies on multimodal analgesia after gastrectomy are scarce. In this study, we introduced a multimodal analgesia strategy consisting of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of an oxycodone/paracetamol mixture and evaluated the effects of this strategy compared with PCIA analgesia which is used widely for pain after gastrectomy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
- •Patients underwent laparoscopic radical gastrectomy under general anesthesia and between the age of 18 and 75 years old without considering sex.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Participants can follow the drug doses and visit plan
排除标准
- •Patients certified by a doctor that doesn't fit to participate in this study.
- •Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc..
- •Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
- •Patients with gastric cancer with distant metastasis.
- •Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
- •Patients with suspect or have a history of drug abuse.
- •Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
- •Sponsors or researchers directly involved in the testing or their family members.
- •Patients with conversion, palliative resection.
- •Patients with chronic pain（NRS≥3）or using opioids or NSAIDs before surgery.
研究组 & 干预措施
multimodal analgesia
Patients received multimodal analgesia after laparoscopic gastrectomy .
干预措施: Multimodal analgesia (Procedure)
PCIA analgesia
Patients received PCIA analgesia after laparoscopic gastrectomy.
干预措施: PCIA analgesia (Procedure)
结局指标
主要结局
Numeric rating scales (NRS) score with 24 hours after the surgery
时间窗: 1 day
pain evaluation
次要结局
- NRS score after 24 hours postoperatively(1 week)
- Total protein(1 year)
- Number of remedial treatment(1 week)
- Time to first off-bed activity(1 week)
- interleukin-6 (IL-6)(1 week)
- Albumin(1 year)
- Prealbumin(1 year)
- Length of off-bed activity per day(1 week)
- Time to first flatus(1 week)
- Time to first semi-liquid diet(1 week)
- Postoperative length of stay(1 month)
- C-reactive protein (CRP)(1 week)
- Time of off-bed activity per day(1 week)
研究者
JIANG Zhi-Wei
Vice director of Research Institute of General Surgery
Jinling Hospital, China