Could a back injection ease the need for life support in pancreatitis?

NCT ID NCT07697690

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This trial is taking on new participants right now.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jul 13, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study tests whether a thoracic epidural block—a numbing injection near the spine—can help people with severe acute pancreatitis avoid or shorten the need for intensive care support like breathing machines and kidney dialysis. Participants are randomly assigned to receive either the epidural block with ropivacaine or standard pain relief. The main goal is to see if the block increases the number of days patients are alive and free from organ support during the first two weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Thoracic epidural block with ropivacaine
What this could lead to
If effective, this pain-blocking technique could reduce the need for breathing machines, kidney support, and strong painkillers in severe pancreatitis patients.
What could go wrong
This is a single-center trial with 120 participants, so results may not apply broadly. The epidural procedure carries risks like bleeding, infection, or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

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