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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
540
Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.
Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Overall survival (OS)
Defined and calculated as the time from the date of surgery to death related to all reasons
Time frame: During 2 years after surgery
Disease-free survival (DFS )
Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death
Time frame: During 2 years after surgery
Postoperative pain score and side effects of patient-controlled analgesia
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Time frame: During the first 48 hours after surgery
Incidence of delirium
Assessed for delirium using the 3D-CAM instrument
Time frame: During the first 1 week after surgery
Incidence of persistent post-surgical pain (PPSP) after surgery
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Time frame: During 2 years after surgery
Length of stay in hospital after surgery and total costs after surgery
Time frame: During the first 30 days after surgery
Return of bowel function
Measured by the time of first flatus
Time frame: During the first 30 days after surgery
Start of enteral tube feeding
Measured by the time of first enteral tube feeding after surgery
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Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Time frame: During the first 30 days after surgery
Removal of Perianastomotic drains
Time frame: During the first 30 days after surgery
Removal of Urinary drainage
Time frame: During the first 30 days after surgery
Removal of nasogastric tube
Time frame: During the first 30 days after surgery
Removal of enteral feeding tube
Time frame: During the first 30 days after surgery
Blood level of neuroendocrine, stress and inflammatory response
Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)
Time frame: During surgery and the first 24 hours after surgery (post-operative day 1)
Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
Time frame: During 2 years after surgery
Plasma levels of ropivacaine and sufentanil
Time frame: During surgery and the first 24 hours after surgery (post-operative day 1)