The benefits of continuous epidural infusion of ropivacaine in acute pancreatitis

INTERVENTION: VNEPIPAN‐HMUIBR968 (The benefits of continuous EPIdural infusion of ropivacaine in acute PANcreatitis) study In the interventional group, thoracic epidural analgesia will be performed using ropivacaine 0,1% with a continuous infusion rate of 5 to 10 mL/h, through continuous infusion via thoracic catheter. It is placed in an intervertebral space between the 8th and the 11th thoracic vertebra. In both groups, conventional analgesia will be included in enteral and/or parenteral administration according to the WHO analgesics ladder (including paracetamol, nefopam, tramadol, and opioids). The route, dose, and frequency of analgesic administrations will be based on clinical doctors of the Center for Critical Care Medicine – Bach Mai Hospital. Analgesia goals are the same in the two groups, with regular evaluation of pain every 4 hours and during routine daily nursing care. The other treatments will be managed by attending physicians, which include fluid resuscitation, correction of electrolyte balance and acid‐base balance, etiological treatment, early enteral nutrition and early mobilization, when possible, diagnosis and treatment of complications. Continuous epidural infusion of ropivacaine in acute pancreatitis may result in pain reduction and organ failure improvement, which may lead to improvement in the outcome of acute pancreatitis. The intervention group received a continuous epidural infusion of ropivacaine during the first 3 ‐ 5 days at the Center for Critical Care Medicine – Bach Mai Hospital (CCCM‐BMH). All other care will be usual practice. Precise details of both intervention content and the training program can be found at (https://1drv.ms/f/s!AjNnyA_Zx7A3g8Zku986BWbogLc0rw? e=ChXr3h, Password:VNEPIPANIRB968) Epidural catheter placement is a routine in CCCM‐BMH CONDITION: Severe and predicted severe acute pancreatitis ; Digestive System PRIMARY OUTCOME: 1. Pain is measured using the Behavioral Pain Scale (BPS) at admission, 0.5, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, and 120 hours; 2. ICU mortality measured using the Sequential Organ Failure Assessment (SOFA) Scores at admission day 1 (D1), day 2 (D2), day 3 (D3), day 4 (D4), day 5 (D5): mean and maximum SOFA score of first 5 days in Center for Critical Care Medicine; 3. Gastrointestinal failure during the ICU stay measured using the Gastrointestinal Failure Score (GIF) at admission day 1 (D1), day 2 (D2), day 3 (D3), day 4 (D4), day 5 (D5): mean GIF scores for the first 5 days; SECONDARY OUTCOME: 1. Pain is measured using a Visual Analogue Scale (VAS) at admission, 0.5, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, and 120 hours; 2. Mortality rate measured using patient records at day 60; 3. Intubation rate measured using patient records at day 30; 4. Number of ventilator‐free days measured using patient records from randomization to day 30; 5. CT Severity Inde X(CTSI) measured using enhanced CT scanning at 72 hours after Center for Critical Care Medicine admission. INCLUSION CRITERIA: 1. Aged = 18 years. 2. Diagnosis of acute pancreatitis required two of the following three features, as per the revised Atlanta definition: abdominal pain consistent with acute pancreatitis, serum lipase activity at least three times greater than the upper limit of normal, and characteristic findings of acute pancreatitis on contrast‐enhanced computed tomography. 3. Onset = 72 h. 4. Pain moderate or severe with visual analog pain scale (VAS) = 4 in consciousness patients or behavioral pain scale (BPS) = 7 in unconsciousness patients. 5. Classification is severe acute pancreatitis (modified Marshall score = 2 on admission) OR predicted severe (at least one of criteria: (1) Ranson's Criteria = 2 points; (2) CRP level > 100 mg/L; (3) Pancreatic necrosis on contrast‐enhanced computed tomography.