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The Application of Thoracic Epidural Analgesia in Patients With Acute Pancreatitis

NCT06327230 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-03-25

No results posted yet for this study

Summary

Acute pancreatitis (AP) is one of the most common diseases of the digestive system, with its incidence increasing year by year. 15%-25% of patients will develop severe acute pancreatitis (SAP), characterized by necrosis and infection of the pancreas and surrounding tissues, as the investigators as multiple organ dysfunction syndrome (MODS), with a mortality rate as high as 17%. Currently, there is a lack of effective measures in clinical practice to regulate the early inflammation and immune response in acute pancreatitis. Animal experimental studies have confirmed that TEA, by blocking the abdominal sympathetic nerves, increases arterial blood flow and venous capacity, improves pancreatic perfusion insufficiency caused by AP, and alleviates metabolic acidosis. Simultaneously, TEA can suppress the secretion of catecholamines during the stress state of acute pancreatitis, reducing the release of inflammatory mediators and thereby inhibiting the inflammatory response. Our team's earlier animal experiments have further confirmed that TEA improves intestinal inflammation in mice with pancreatitis. This improvement is marked by a significant reduction in the concentrations of inflammatory cytokines such as IL-1β and TNF-α. Additionally, there is an observed alteration in the intestinal microbiota, characterized by an increase in the proportion of beneficial bacteria. Based on these findings, it is speculated that TEA, by reducing catecholamine release and downregulating sympathetic activity, effectively mitigates inflammation and stress responses in patients with pancreatitis. Furthermore, TEA dilates small arteries in blocked segments, thereby improving blood flow and microcirculation within the affected area. Indirectly, TEA increases vagal nerve activity, which in turn slows down the progression of intestinal ischemia, consequently reducing the impact of the "second hit" caused by the translocation of intestinal bacteria and endotoxins into the bloodstream, which exacerbates acute pancreatitis. Despite these promising results, clinical data on the efficacy of TEA in acute pancreatitis remains insufficient. Moreover, the precise mechanisms by which TEA influences the progression and severity of acute pancreatitis are yet to be fully elucidated. In order to further validate the clinical therapeutic effects of TEA and gain a deeper understanding of its mechanisms, the investigators have conducted this clinical study.

Conditions

Interventions

PROCEDURE

Thoracic Epidural Analgesia

Thoracic epidural analgesia is performed by a standardized anesthesia team. Patients are positioned in the lateral decubitus position, and routine disinfection is performed. The puncture site is selected at the T7-T9 level. When encountering sudden disappearance of resistance and appearance of negative pressure during needle advancement, it is determined that the needle has entered the epidural space. After confirming needle tip placement in the epidural space with a test dose, an epidural catheter is inserted approximately 3-5cm cephalad and securely fixed in place. The test dose consists of 3 mL of 1% lidocaine injection solution, administered to observe the level of anesthesia, confirming the effectiveness and safety of the epidural anesthesia. Subsequently, a maintenance regimen of 0.15% ropivacaine 250mL with 2.5mg of hydroma.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Principal Investigators

  • hong yu · sir run run shaw hospital，hangzhou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06327230 on ClinicalTrials.gov