Thoracic Epidural Analgesia for Acute Pancreatitis With Early Organ Dysfunction

Официальное название

Effect of Thoracic Epidural Analgesia on Organ Support Burden in Patients With Acute Pancreatitis and Early Organ Dysfunction: A Single-Center Randomized Controlled Trial

Обзор

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.

Вмешательства

• Процедура Thoracic Epidural Analgesia With Ropivacaine
  Thoracic epidural block will be performed by an investigator qualified to perform neuraxial procedures and trained in the study protocol. Before catheterization, the clinical team will assess hemodynamic status, coagulation function, antithrombotic medication use, infection risk, respiratory status, and baseline neurological status. The puncture level will be selected according to the participant's condition and operator assessment, generally within the T7-T11 range to cover upper abdominal pain
• Другое conventional analgesia
  Conventional analgesia will be administered according to institutional practice and the participant's clinical condition. The analgesic target is an NRS score of 3 or less in conscious and communicative participants, or a CPOT score of 2 or less in non-communicative critically ill participants. Analgesic drugs, doses, routes, duration of administration, rescue analgesia, sedative use, and opioid consumption will be recorded.

Первичные конечные точки

• Alive and Organ Support-Free Days Through Day 14 (AOSFD-14) [Срок оценки: From randomization through day 14]

Вторичные конечные точки (7)

• Organ Failure-Free Days to Day 14 [Срок оценки: From randomization to day 14]
• Alive Organ Support-Free Days to Day 28 [Срок оценки: From randomization to day 28]
• Ventilator-Free Days to Day 28 [Срок оценки: From randomization to day 28]
• Renal Replacement Therapy-Free Days to Day 28 [Срок оценки: From randomization to day 28]
• Vasoactive Drug-Free Days to Day 28 [Срок оценки: From randomization to day 28]
• Pain Score [Срок оценки: Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7]
• Analgesic Target Achievement Rate [Срок оценки: From randomization to day 7]

Критерии участия

Критерии включения

Критерии включения

• Age 18 to 75 years, inclusive.
• Diagnosis of acute pancreatitis based on at least two of the following three criteria: typical acute upper abdominal pain; serum amylase and/or lipase at least three times the upper limit of normal; or imaging findings consistent with acute pancreatitis.
• Time from symptom onset to randomization of 72 hours or less.
• Early respiratory, cardiovascular, or renal organ dysfunction, defined as a SOFA-2 subscore of 2 or greater in at least one of these three organ systems, requiring ICU admission for continuous monitoring and treatment. The SOFA-2 score will be calculated using the worst available values during the 24 hours before randomization; for participants admitted to the ICU for less than 24 hours, values available since ICU admission will be used. The organ dysfunction must be newly developed or clearly worsened from the participant's previous stable baseline.
• Written informed consent provided by the participant or legally authorized representative.

Критерии исключения

• Pregnancy or lactation.
• Chronic pancreatitis or acute pancreatitis associated with a pancreatic tumor.
• Prior retroperitoneal drainage, endoscopic drainage, surgical necrosectomy, or other invasive intervention before randomization that may substantially alter the natural course of the disease.
• Invasive mechanical ventilation before randomization.
• Any contraindication to thoracic epidural analgesia, including allergy to local anesthetics; infection at the puncture site; epidural abscess or central nervous system infection; severe spinal deformity or prior spinal surgery that prevents catheterization; intracranial hypertension or severe central nervous system disease; uncorrected coagulation disorder; or anticoagulant or antiplatelet therapy that does not meet neuraxial safety requirements.
• Uncorrected shock or persistent hemodynamic instability despite adequate fluid resuscitation and vasoactive drug support.
• End-stage renal disease requiring maintenance dialysis before randomization.
• Participation in another interventional clinical study within the previous 3 months.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07697690 · TEA-AP-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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