Thoracic Epidural Block for Severe Acute Pancreatitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst People's Hospital of Chenzhou

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 to 75 years.

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.

Admission or transfer to the study hospital within 72 hours after symptom onset.

Severe acute pancreatitis, or moderately severe acute pancreatitis with early respiratory, cardiovascular, or renal organ dysfunction.

Disqualifiers

Acute exacerbation of chronic pancreatitis.

Acute pancreatitis associated with pancreatic tumor.

Pregnancy or lactation.

Prior percutaneous abdominal drainage, retroperitoneal drainage, endoscopic drainage, necrosectomy, or surgery before randomization that may substantially affect outcome assessment.

Trial design

Treatments tested in this trial

  • Thoracic Epidural Block With Ropivacaine
  • conventional analgesia

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

This trial has no locations