Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 540
- 试验地点
- 3
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective distal pancreatectomy for pancreatic cancer .
- •ASA statusⅠ-Ⅲ.
- •18 years to 80 years （adults）.
- •Able to understand, communicate and sign an informed consent form.
排除标准
- •Laparoscopic surgery.
- •Preoperative chemotherapy or radiotherapy.
- •Allergic to any drugs used during the study.
- •Long-term receiving β-blockers.
- •Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
- •Abnormal coagulation functions (platelet count prior to surgery <100000/ μL , APTT value is more than the normal value, INR > 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).
- •Complicated with severe heart disease (NYHA classification >3), severe renal insufficiency (serum creatinine >1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification=C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC>10000/μL) before surgery.
- •All contraindications to epidural block.
- •Chronic opiate medication/drug abuse.
- •Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
- •Refuse to sign an informed consent form.
研究组 & 干预措施
GEA+PCEA
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
干预措施: GEA (Other)
GEA+PCEA
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
干预措施: PCEA (Other)
GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
干预措施: GA (Other)
GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
干预措施: PCIA (Other)
结局指标
主要结局
Overall survival (OS)
时间窗: During 2 years after surgery
Defined and calculated as the time from the date of surgery to death related to all reasons
次要结局
- Disease-free survival (DFS )(During 2 years after surgery)
- Postoperative pain score and side effects of patient-controlled analgesia(During the first 48 hours after surgery)
- Incidence of delirium(During the first 1 week after surgery)
- Incidence of persistent post-surgical pain (PPSP) after surgery(During 2 years after surgery)
- Length of stay in hospital after surgery(During the first 30 days after surgery)
- Return of bowel function(During the first 30 days after surgery)
- Removal of Perianastomotic drains(During the first 30 days after surgery)
- Removal of Urinary drainage(During the first 30 days after surgery)
- Removal of nasogastric tube(During the first 30 days after surgery)
- Blood level of neuroendocrine, stress and inflammatory response(During surgery and the first 24 hours after surgery)
- Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels(During 2 years after surgery)
- Blood levels of ropivacaine and sufentanil(During surgery and the first 24 hours after surgery)
研究者
Changhong Miao
Director of Anesthesiology Department of Fudan University Shanghai Cancer Center
Fudan University