Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery: A Multi-center Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- GEA
- Conditions
- Cancer of Pancreas
- Sponsor
- Fudan University
- Enrollment
- 540
- Locations
- 3
- Primary Endpoint
- Overall survival (OS)
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Changhong Miao
Director of Anesthesiology Department of Fudan University Shanghai Cancer Center
Fudan University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
GEA+PCEA
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
Intervention: GEA
GEA+PCEA
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
Intervention: PCEA
GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
Intervention: GA
GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
Intervention: PCIA
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: During 2 years after surgery
Defined and calculated as the time from the date of surgery to death related to all reasons
Secondary Outcomes
- 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))