Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this randomized controlled trial is to investigate the effects of epidural anesthesia and analgesia on the overall survival，disease-free survival and recovery in patients undergoing pancreatic cancer surgery. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective pancreaticoduodenectomy 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 anesthesia and analgesia.
- •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 (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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
- Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels(During 2 years after surgery)
- Incidence of delirium(During the first 1 week after surgery)
- Removal of Perianastomotic drains(During the first 30 days after surgery)
- Incidence of persistent post-surgical pain (PPSP) after surgery(During 2 years after surgery)
- Return of bowel function(During the first 30 days after surgery)
- Removal of Urinary drainage(During the first 30 days after surgery)
- Length of stay in hospital after surgery and total costs after surgery(During the first 30 days after surgery)
- Removal of enteral feeding 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 (post-operative day 1))
- Postoperative pain score and side effects of patient-controlled analgesia(During the first 48 hours after surgery)
- Removal of nasogastric tube(During the first 30 days after surgery)
- Disease-free survival (DFS )(During 2 years after surgery)
- Start of enteral tube feeding(During the first 30 days after surgery)
- Plasma levels of ropivacaine and sufentanil(During surgery and the first 24 hours after surgery (post-operative day 1))
研究者
Changhong Miao
Director of Anesthesiology Department of Fudan University Shanghai Cancer Center
Fudan University