Thoracic Epidural Block for Severe Acute Pancreatitis (TEB-SAP)

First People's Hospital of Chenzhou

Status: Begins enrollment this month

Conditions: Organ Support; Organ Dysfunction; Severe Acute Pancreatitis

Treatments: Procedure: Thoracic Epidural Block With Ropivacaine; Other: conventional analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07697690

TEB-SAP-001

Details and patient eligibility

About

Severe acute pancreatitis is a serious illness that can cause severe abdominal pain, inflammation, increased abdominal pressure, feeding intolerance, and early problems with breathing, circulation, and kidney function. Patients with severe acute pancreatitis often need treatment in the intensive care unit. Pain control is an important part of treatment, but conventional pain medicines, especially opioids, may cause side effects such as respiratory depression, reduced bowel movement, nausea, vomiting, delirium, and delayed enteral nutrition.

Thoracic epidural block is a regional pain-control technique. It may relieve abdominal pain by blocking pain signals and sympathetic nerve activity from the chest and upper abdominal region. This treatment may also reduce the need for systemic opioid medicines, improve bowel function, improve tolerance to enteral nutrition, and reduce the need for early organ support in some patients.

This study is a single-center, prospective, randomized, open-label, parallel-group trial. Adult patients with severe acute pancreatitis will be randomly assigned to either a thoracic epidural block group or a conventional analgesia group. Patients in the thoracic epidural block group will receive continuous thoracic epidural infusion of ropivacaine alone, without epidural opioids such as sufentanil, fentanyl, or morphine. Intravenous pain medicines will be used only before epidural block initiation, as rescue analgesia when epidural pain control is inadequate, or after epidural block is paused, fails, or is discontinued. Patients in the conventional analgesia group will receive standard pain treatment according to clinical practice.

The main goal of this study is to determine whether thoracic epidural block can increase the number of days patients are alive and free from ICU-level organ support during the first 14 days after randomization. ICU-level organ support includes invasive mechanical ventilation, noninvasive ventilation, vasoactive or inotropic drug infusion, and renal replacement therapy. The study will also evaluate pain scores, opioid consumption, enteral nutrition tolerance, intra-abdominal pressure, organ function scores, complications, length of ICU and hospital stay, hospital cost, 28-day mortality, and adverse events related to thoracic epidural block.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 to 75 years.
2. Diagnosis of acute pancreatitis, defined by at least two of the following three criteria: typical acute upper abdominal pain; serum amylase and/or lipase greater than three times the upper limit of normal; imaging findings consistent with acute pancreatitis on contrast-enhanced CT, MRI, or ultrasound.
3. Admission or transfer to the study hospital within 72 hours after symptom onset.
4. Severe acute pancreatitis, or moderately severe acute pancreatitis with early respiratory, cardiovascular, or renal organ dysfunction.
5. Expected need for hospitalization and continuous clinical observation for at least 72 hours.
6. Written informed consent provided by the participant or legally authorized representative.

Exclusion criteria

1. Acute exacerbation of chronic pancreatitis.
2. Acute pancreatitis associated with pancreatic tumor.
3. Pregnancy or lactation.
4. Prior percutaneous abdominal drainage, retroperitoneal drainage, endoscopic drainage, necrosectomy, or surgery before randomization that may substantially affect outcome assessment.
5. End-stage malignant disease or expected survival less than 3 months.
6. Severe pre-existing cardiac, pulmonary, hepatic, renal, hematologic, immune, or neurological disease judged by investigators to interfere with outcome assessment.
7. Severe pre-existing neurological disease that prevents assessment of neurological complications.
8. Coagulopathy or bleeding risk judged to contraindicate epidural catheterization, including severe thrombocytopenia, elevated INR, prolonged APTT, or other clinically significant coagulation abnormality.
9. Ongoing anticoagulant or antiplatelet therapy for which discontinuation does not meet neuraxial anesthesia safety requirements.
10. Puncture site infection, epidural abscess, central nervous system infection, or uncontrolled severe systemic infection.
11. Severe spinal deformity, prior relevant spinal surgery, or anatomical abnormality that prevents safe thoracic epidural catheterization.
12. Intracranial hypertension, spinal cord disease, radiculopathy, or other central nervous system disorder that contraindicates neuraxial block.
13. Known allergy to local anesthetics or other study-related medications.
14. Refractory shock or severe hemodynamic instability not suitable for thoracic epidural block.
15. Severe psychiatric disease, cognitive impairment, or inability to cooperate with the study without availability of a legally authorized representative.
16. Participation in another interventional clinical trial within the previous 3 months.
17. Any other condition that, in the opinion of the investigators, makes the participant unsuitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Thoracic Epidural Block Group

Experimental group

Description:

Participants in this group will receive thoracic epidural block and standard treatment for severe acute pancreatitis. Thoracic epidural catheterization will be performed by trained anesthesiologists after assessment of hemodynamic status, coagulation function, infection risk, respiratory status, and baseline neurological status. Epidural infusion will use ropivacaine alone. No epidural opioid, including sufentanil, fentanyl, or morphine, will be added. After successful initiation of thoracic epidural block and achievement of the analgesic target, routine intravenous opioid analgesia will not be used in this group. Intravenous analgesics will be allowed only as transitional analgesia before epidural block initiation, rescue analgesia when epidural analgesia is inadequate, or analgesia after epidural block is paused, fails, or is discontinued. All systemic analgesic use and opioid consumption will be recorded.

Treatment:

Procedure: Thoracic Epidural Block With Ropivacaine

Conventional Analgesia Group

Active Comparator group

Description:

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.

Treatment:

Other: conventional analgesia