Effects of thoracic epidural anesthesia in patients with acute pancreatitis and early organ failure: a multicenter, open-label, randomized, parallel- controlled trial
Effective interventions to improve organ function and prognosis in patients with acute pancreatitis
Randomization was performed using a stratified block design with randomly permuted block sizes, stratified by center, via a computer-generated program. Patients will be randomized to receive thoracic epidural analgesia for at least 5 days and a maximum of 7 days (intervention group) or conventional analgesic treatment (control group). Patients assigned to the intervention group will receive TEA as soon as possible after randomization. An epidural catheter was placed in an intervertebral space between the eighth and tenth thoracic vertebrae by a certified anesthesiologist. A test dose of 3 mL of 1% lidocaine was administered to assess the anesthetic level and confirm the efficacy and safety of epidural anesthesia. Upon confirmation, 0.15% ropivacaine 250mL + sufentanil 0.3 μg/mL was administered via continuous infusion at 5-7 mL/h. According to clinical analgesic requirements, a bolus of 2-3 mL was added as necessary. Patients assigned to the control group will receive conventional analgesic treatment. The analgesic treatment was based on the WHO analgesic ladder, including intravenous administration of nonsteroidal anti-inflammatory drugs (e.g., flurbiprofen) and intravenous administration of opioid analgesics (e.g., tramadol). Pain was assessed every 4 hours on the day of surgery (within 24 hours). From the second day post-surgery until the day of catheter removal, pain was assessed three times daily (every 8 hours). Pain management goals were similar among both groups: an NRS (Numeric Rating Scale) score of ≤3 in communicative patients with intact consciousness, or a CPOT (Critical-Care Pain Observation Tool) score of ≤2 in non-communicative patients.
1. Aged between 18 and 70 years 2. Admitted to the hospital within 72 h of the onset of abdominal pain, diagnosed with acute pancreatitis 3. With organ failure as defined by the sequential organ failure assessment-2(SOFA-2)score for respiration, renal and cardiovascular systems 4. Voluntary participation; signed informed consent required
1. Pregnant or lactating women, or those planning pregnancy within 6 months 2. Acute pancreatitis associated with chronic pancreatitis or pancreatic neoplasms 3. Patients who have undergone retroperitoneal percutaneous drainage 4. Post-cardiopulmonary resuscitation status with unresolved neurological dysfunction 5. Patients with a history of severe primary cardiovascular, respiratory, renal, hepatic, hematological, malignant tumor, or immune diseases 6. Patients with contraindications to TEA: those who are allergic to local anesthetics; those accompanied by severe systemic infection, infection at the puncture site, epidural abscess, or central nervous system infection; those with central nervous system diseases such as spinal cord lesions, spinal nerve root lesions, or intracranial hypertension; patients in shock; those with anatomical variations or a history of back surgery related to the epidural space, making TEA impossible; those with coagulation disorders or those who have not met the required withdrawal time for anticoagulant or antiplatelet medications; those with mental illness, severe neurosis, or other conditions that make cooperation impossible. 7. Participation in other interventional clinical studies within the past 3 months 8. Other conditions deemed unsuitable for inclusion by the investigator