Effect of Thoracic Epidural Analgesia on Organ Support Burden in Patients With Acute Pancreatitis and Early Organ Dysfunction: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Alive Organ Support-Free Days to Day 14
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of thoracic epidural catheter placement and continuous epidural infusion, blinding of participants and treating clinicians is not feasible. The study will use an open-label design. The primary outcome will be calculated according to prespecified objective criteria based on ICU-level organ support. Statistical analysis will be performed according to a prespecified analysis plan.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •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.
排除标准
- •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.
研究组 & 干预措施
Thoracic Epidural Analgesia Group
Participants will receive standard treatment for acute pancreatitis plus thoracic epidural analgesia using ropivacaine alone. After initial fluid resuscitation, blood pressure stabilization, and safety assessment, thoracic epidural analgesia will be initiated as soon as possible after randomization, preferably within 6 hours, no later than 24 hours after randomization, and before 72 hours from symptom onset.
Epidural catheterization will be performed at T8-T11, preferably T9-T10 or T10-T11, by an investigator qualified to perform neuraxial procedures and trained in the study protocol. After a negative test dose of 1% lidocaine 3 mL, a loading dose of 0.2% ropivacaine 5-10 mL will be administered, followed by continuous infusion of 0.2% ropivacaine at 6-8 mL/hour. The target sensory block is T6-T12 and should cover the main upper abdominal pain area.
Thoracic epidural analgesia will generally continue for 5 days or until ICU discharge if earlier. It may be extended to a maximum of 7
干预措施: Thoracic Epidural Analgesia With Ropivacaine (Procedure)
Conventional Analgesia Group
Participants in this group will receive conventional analgesia and standard treatment for severe acute pancreatitis. Conventional analgesia may include non-steroidal anti-inflammatory drugs, acetaminophen, tramadol, fentanyl, sufentanil, oxycodone, hydromorphone, morphine, dexmedetomidine, or other analgesic and sedative medications according to clinical judgment. Analgesic drugs, doses, routes, duration of administration, rescue analgesia, sedative use, and opioid consumption will be recorded.
干预措施: conventional analgesia (Other)
结局指标
主要结局
Alive Organ Support-Free Days to Day 14
时间窗: From randomization to day 14
Alive organ support-free days to day 14 is defined as the number of days from randomization to day 14 during which the participant is alive and free of ICU-level organ support. ICU-level organ support includes invasive mechanical ventilation, noninvasive ventilation, continuous infusion of vasoactive or inotropic drugs, and renal replacement therapy. A day will be counted as organ support-free only if the participant is alive and does not receive any of these organ support treatments on that day. Participants who die within 14 days after randomization will be assigned 0 alive organ support-free days.
Alive and Organ Support-Free Days Through Day 14 (AOSFD-14)
时间窗: From randomization through day 14
Alive organ support-free days to day 14 is defined as the number of days from randomization to day 14 during which the participant is alive and free of ICU-level organ support. ICU-level organ support includes invasive mechanical ventilation, noninvasive ventilation, continuous infusion of vasoactive or inotropic drugs, and renal replacement therapy. A day will be counted as organ support-free only if the participant is alive and does not receive any of these organ support treatments on that day. Participants who die within 14 days after randomization will be assigned 0 alive organ support-free days.
次要结局
- Organ Failure-Free Days to Day 14(From randomization to day 14)
- Alive Organ Support-Free Days to Day 28(From randomization to day 28)
- Ventilator-Free Days to Day 28(From randomization to day 28)
- Renal Replacement Therapy-Free Days to Day 28(From randomization to day 28)
- Vasoactive Drug-Free Days to Day 28(From randomization to day 28)
- Analgesic Target Achievement Rate(From randomization to day 7)
- Pain Score(Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7)
研究者
Xingui Dai
Principal Investigator
First People's Hospital of Chenzhou