Thoracic Epidural Analgesia for Acute Pancreatitis With Early Organ Dysfunction

NCT07697690 | Not Yet Recruiting

• 1 other identifier: TEA-AP-001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Organ Dysfunction; Organ Support; Acute Pancreatitis (AP)

Keywords

Thoracic epidural block; Ropivacaine; Organ support-free days; Opioid consumption; acute pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization through day 14

Secondary Outcomes (7)

• 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

Study Arms (2)

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

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.

Other: conventional analgesia

Interventions

conventional analgesia OTHER

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.

Also known as: Standard analgesia, Conventional pain management, Systemic analgesia

Conventional Analgesia Group

Thoracic Epidural Analgesia With Ropivacaine PROCEDURE

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.

Also known as: TEA, Thoracic epidural analgesia, Thoracic epidural blockade, Thoracic epidural catheterization

Thoracic Epidural Analgesia Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Chenzhou: lead

MeSH Terms

Conditions

Pancreatitis

Interventions

Tea; Ropivacaine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Xingui Dai, PHD

  Chen Zhou NO.1 People's Hospital

  STUDY CHAIR

Central Study Contacts

Feng Yang, MM

CONTACT

+8615886524007; 202020321@sr.gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the main study results and available for 3 years.
• Access Criteria: 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.