Organ Dysfunction, Organ Support, Acute Pancreatitis (AP)
Conditions
Keywords
Thoracic epidural block, Ropivacaine, Organ support-free days, Opioid consumption, acute pancreatitis
Brief 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.
Interventions
PROCEDUREThoracic 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. After thoracic epidural catheter placement, a test dose of 1%-1.5% lidocaine 3 mL will be administered to exclude intrathecal or intravascular catheter placement. If the test dose is negative, a loading dose of ropivacaine may be administered, followed by continuous thoracic epidural infusion of ropivacaine alone. No epidural opioid, including sufentanil, fentanyl, or morphine, will be added to the epidural infusion in this study.
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.
Sponsors
First People's Hospital of Chenzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Age 18 to 75 years, inclusive. 2. 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. 3. Time from symptom onset to randomization of 72 hours or less. 4. 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. 5. Written informed consent provided by the participant or legally authorized representative.
Exclusion criteria
1. Pregnancy or lactation. 2. Chronic pancreatitis or acute pancreatitis associated with a pancreatic tumor. 3. Prior retroperitoneal drainage, endoscopic drainage, surgical necrosectomy, or other invasive intervention before randomization that may substantially alter the natural course of the disease. 4. Invasive mechanical ventilation before randomization. 5. 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. 6. Uncorrected shock or persistent hemodynamic instability despite adequate fluid resuscitation and vasoactive drug support. 7. End-stage renal disease requiring maintenance dialysis before randomization. 8. Participation in another interventional clinical study within the previous 3 months. 9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alive and Organ Support-Free Days Through Day 14 (AOSFD-14) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ Failure-Free Days to Day 14 | From randomization to day 14 | Number of days from randomization to day 14 during which the participant is alive and free of respiratory, cardiovascular, and renal organ failure. Organ failure is defined as a SOFA subscore of 2 or higher in any of the following systems: respiratory, cardiovascular, or renal. Participants who die within 14 days will be assigned 0 organ failure-free days. |
| Alive Organ Support-Free Days to Day 28 | From randomization to day 28 | Number of days from randomization to day 28 during which the participant is alive and free of ICU-level organ support, including invasive mechanical ventilation, noninvasive ventilation, vasoactive or inotropic drug infusion, and renal replacement therapy. Participants who die within 28 days will be assigned 0 days. |
| Ventilator-Free Days to Day 28 | From randomization to day 28 | Number of days from randomization to day 28 during which the participant is alive and free of invasive mechanical ventilation. Participants who die within 28 days will be assigned 0 ventilator-free days. |
| Renal Replacement Therapy-Free Days to Day 28 | From randomization to day 28 | Number of days from randomization to day 28 during which the participant is alive and free of renal replacement therapy. Renal replacement therapy includes continuous renal replacement therapy and intermittent hemodialysis for acute kidney injury. Participants who die within 28 days will be assigned 0 days. |
| Vasoactive Drug-Free Days to Day 28 | From randomization to day 28 | Number of days from randomization to day 28 during which the participant is alive and free of vasoactive or inotropic drug infusion. Vasoactive or inotropic drugs include norepinephrine, epinephrine, dopamine, vasopressin, dobutamine, or other agents used for shock or circulatory support. Participants who die within 28 days will be assigned 0 days. |
| Pain Score | Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7 | Pain intensity will be assessed using the Numeric Rating Scale (NRS) in conscious and communicative participants, or the Critical-Care Pain Observation Tool (CPOT) in non-communicative critically ill participants. The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). The CPOT ranges from 0 (no pain) to 8 (worst possible pain). For both scales, higher scores indicate worse pain control (worse outcome). |
| Analgesic Target Achievement Rate | From randomization to day 7 | Total systemic opioid consumption during the first 7 days after randomization, converted to intravenous morphine equivalent dose when applicable. |
Contacts
CONTACTFeng Yang, MM
STUDY_CHAIRXingui Dai, PHD
Chen Zhou NO.1 People's Hospital
Outcome results
None listed