Thoracic Epidural Analgesia for Acute Pancreatitis With Early Organ Dysfunction (TEA-APOD)
19 de julio de 2026 actualizado por: Xingui Dai, First People's Hospital of Chenzhou
Effect of Thoracic Epidural Analgesia on Organ Support Burden in Patients With Acute Pancreatitis and Early Organ Dysfunction: A Single-Center Randomized Controlled Trial
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.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
150
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Feng Yang, MM
- Número de teléfono: +8615886524007
- Correo electrónico: 202020321@sr.gxmu.edu.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: 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.
|
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.
Otros nombres:
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Experimental: 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 |
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Alive and Organ Support-Free Days Through Day 14 (AOSFD-14)
Periodo de tiempo: 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.
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From randomization through day 14
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Organ Failure-Free Days to Day 14
Periodo de tiempo: 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.
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From randomization to day 14
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Alive Organ Support-Free Days to Day 28
Periodo de tiempo: 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.
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From randomization to day 28
|
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Ventilator-Free Days to Day 28
Periodo de tiempo: 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.
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From randomization to day 28
|
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Renal Replacement Therapy-Free Days to Day 28
Periodo de tiempo: 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.
|
From randomization to day 28
|
|
Vasoactive Drug-Free Days to Day 28
Periodo de tiempo: 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.
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From randomization to day 28
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Analgesic Target Achievement Rate
Periodo de tiempo: From randomization to day 7
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Total systemic opioid consumption during the first 7 days after randomization, converted to intravenous morphine equivalent dose when applicable.
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From randomization to day 7
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Pain Score
Periodo de tiempo: Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7
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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). |
Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Silla de estudio: Xingui Dai, PHD, Chen Zhou NO.1 People's Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
1 de agosto de 2026
Finalización primaria (Estimado)
Finalización primaria
1 de agosto de 2028
Finalización del estudio (Estimado)
Finalización del estudio
1 de septiembre de 2028
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
21 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
19 de julio de 2026
Última verificación
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- TEA-AP-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Deidentified individual participant data underlying the published results may be made available upon reasonable request after publication of the main study results.
Data sharing will require approval by the principal investigator and the institution, and by the ethics committee when applicable.
Data will be shared only for scientifically valid analyses and after signing an appropriate data use agreement.
Marco de tiempo para compartir IPD
Beginning 6 months after publication of the main study results and available for 3 years.
Criterios de acceso compartido de IPD
Qualified researchers may submit a written request including research purpose, analysis plan, requested data elements, and data protection measures.
Requests will be reviewed by the principal investigator and the institution.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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