Organ DysfunctionTEA-APODNCT07697690
Thoracic Epidural Analgesia for Acute Pancreatitis With Early Organ Dysfunction
A study testing Thoracic Epidural Analgesia With Ropivacaine and conventional analgesia in people with Organ Dysfunction and Organ Support, run by First People's Hospital of Chenzhou.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Organ Dysfunction, Organ Support, Acute Pancreatitis (AP)
- What is being tested?
- Thoracic Epidural Analgesia With Ropivacaine and conventional analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Organ Dysfunction, Organ Support, Acute Pancreatitis (AP)
- Being tested
- Thoracic Epidural Analgesia With Ropivacaine, conventional analgesia
- Keywords
- Thoracic epidural block, Ropivacaine, Organ support-free days, Opioid consumption, acute pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Epidural Analgesia With RopivacaineProcedure or surgery
Also called TEA, Thoracic epidural analgesia, Thoracic epidural blockade, Thoracic epidural catheterization
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 analgesiaOther
Also called Standard analgesia, Conventional pain management, Systemic 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.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Epidural Analgesia Group | Experimental | 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 Receives: Procedure: Thoracic Epidural Analgesia With Ropivacaine |
| Conventional Analgesia Group | Active comparator | 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. Receives: Other: conventional analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive and Organ Support-Free Days Through Day 14 (AOSFD-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.
Measured: From randomization through day 14
Secondary outcomes (7)
Organ Failure-Free Days 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.
Measured: From randomization to day 14
Alive Organ Support-Free Days 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.
Measured: From randomization to day 28
Ventilator-Free Days 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.
Measured: From randomization to day 28
Renal Replacement Therapy-Free Days 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.
Measured: From randomization to day 28
Vasoactive Drug-Free Days 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.
Measured: From randomization to day 28
Pain Score
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).
Measured: Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7
Analgesic Target Achievement Rate
Total systemic opioid consumption during the first 7 days after randomization, converted to intravenous morphine equivalent dose when applicable.
Measured: From randomization to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingui Dai, First People's Hospital of Chenzhou
- Investigators
- Xingui Dai, PHD, Study chair, Chen Zhou NO.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697690
- Sponsor's protocol ID
- TEA-AP-001
- Acronym
- TEA-APOD
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Epidural Analgesia on Organ Support Burden in Patients With Acute Pancreatitis and Early Organ Dysfunction: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07697690
- Acronym / sponsor ID
- TEA-APOD / TEA-AP-001
- Conditions
- Organ Dysfunction, Organ Support, Acute Pancreatitis (AP)
- Keywords
- Thoracic epidural block, Ropivacaine, Organ support-free days, Opioid consumption, acute pancreatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Epidural Analgesia Group | Experimental | Procedure: Thoracic Epidural Analgesia With RopivacaineParticipants 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 |
| Conventional Analgesia Group | Active comparator | Other: conventional analgesiaParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Epidural Analgesia With RopivacaineAlso: TEA, Thoracic epidural analgesia, Thoracic epidural blockade, Thoracic epidural catheterizationThoracic 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. | Procedure or surgery | Thoracic Epidural Analgesia Group |
| conventional analgesiaAlso: Standard analgesia, Conventional pain management, Systemic analgesiaConventional 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. | Other | Conventional Analgesia Group |
Primary outcome
Alive and Organ Support-Free Days Through Day 14 (AOSFD-14)
Time frame: 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.
7 secondary outcomes
Organ Failure-Free Days to Day 14
Time frame: From randomization to day 14
Alive Organ Support-Free Days to Day 28
Time frame: From randomization to day 28
Ventilator-Free Days to Day 28
Time frame: From randomization to day 28
Renal Replacement Therapy-Free Days to Day 28
Time frame: From randomization to day 28
Vasoactive Drug-Free Days to Day 28
Time frame: From randomization to day 28
Pain Score
Time frame: Baseline, 3-6 hours after intervention initiation, and days 1, 3, 5, and 7
Analgesic Target Achievement Rate
Time frame: From randomization to day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingui Dai, PHD study chair
Chen Zhou NO.1 People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Epidural Analgesia With Ropivacaine and conventional analgesia in people with Organ Dysfunction and Organ Support, run by First People's Hospital of Chenzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Yang, MM (+8615886524007, 202020321@sr.gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alive and Organ Support-Free Days Through Day 14 (AOSFD-14) (time frame: From randomization through day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.