Clinical Trial

Thoracic Epidural Analgesia for Acute Pancreatitis With Early Organ Dysfunction

Study acronym: TEA-APOD
Not Yet Recruiting
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Summary
Acute pancreatitis may cause early respiratory, cardiovascular, or renal dysfunction and may require intensive care and organ support. Thoracic epidural analgesia may improve pain control, reduce systemic opioid exposure, and facilitate gastrointestinal recovery; however, its effect on overall organ support burden remains uncertain. This is a single-center, prospective, randomized, open-label, parallel-group clinical trial. A total of 150 adults with acute pancreatitis within 72 hours of symptom onset and early respiratory, cardiovascular, or renal dysfunction will be randomized in a 1:1 ratio to receive either ropivacaine-only thoracic epidural analgesia plus standard care or standardized conventional analgesia plus standard care. The primary outcome is alive and organ support-free days through day 14 after randomization. Secondary and exploratory outcomes include alive and organ support-free days through day 28, organ dysfunction-free days, ventilator-free days, renal replacement therapy-free days, vasoactive drug-free days, 28-day mortality, pain scores, systemic opioid exposure, gastrointestinal and nutritional outcomes, intra-abdominal pressure, inflammatory markers, complications, length of stay, hospital costs, and adverse events related to thoracic epidural analgesia.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-07-22
notable Enrollment increased: 120 -> 150 participants 2026-07-22
Trial Details
NCT Number NCT07697690
Lead Sponsor First People's Hospital of Chenzhou
Conditions Organ Dysfunction, Organ Support, Acute Pancreatitis (AP)
Enrollment 150 participants
Start Date 2026-08-01
Primary Completion 2028-08-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-21