The Application of Thoracic Epidural Analgesia in Patients With Acute Pancreatitis

NCT06327230 | Active Not Recruiting DMC

• 1 other identifier: SRRSH2023-0627
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Acute Pancreatitis

Outcome Measures

Primary Outcomes (3)

• The change in systemic inflammatory response syndrome (SIRS) and organ dysfunction after inclusion.

  SIRS score, APACHE II score, Marshall Organ Dysfunction Score.

  Day0,1,3,5,7

• The change in intra-abdominal pressure (measured via bladder pressure) after treatment.

  obtained from measured data

  day0，"3-6 hours post-treatment"，day1,3,5,7

• The change in resting pain and movement pain after inclusion.

  When patients are in a state of endotracheal intubation, use the Critical Care Pain Observation Tool (CPOT) for assessment.

  day0，"3-6 hours post-treatment"，day1,3,5,7

Secondary Outcomes (4)

• Peripheral blood inflammation and immune markers.

  From the date of randomization (day 0) and at days 1, 3, 5, and 7.

• intestinal microbiota

  From the date of randomization (day 0) and at days 1, 3, 5, and 7.

• total ICU treatment time

  From the date of randomization until the first documented record of the patient being transferred out of the ICU，assessed up to 6 months

• adverse event occurrence rate

  From the date of randomization until the first documented occurrence of an adverse event，assessed up to 2 months

Study Arms (2)

"Non-TEA group"

NO INTERVENTION

After enrollment, the subjects are given standard treatment, including continuous monitoring of vital signs, pain control with intravenous non-steroidal anti-inflammatory drugs (such as ibuprofen) and intravenous opioids (such as tramadol), goal-directed intravenous fluid resuscitation, correction of electrolyte and metabolic disturbances, nutritional support, use of antibiotics and sedatives as needed, necessary mechanical ventilation, continuous renal replacement therapy (CRRT) and other organ support therapies as needed.

TEA group

EXPERIMENTAL

Patient in lateral position, standard disinfection, puncture point selected at T7-T9 level, local anesthesia to pierce skin. Direct/lateral needle approach cautiously, confirm entry into epidural space with disappearance of resistance and negative pressure. Insert epidural catheter 3-5cm towards head, secure firmly. Test dose with 3mL 1% lidocaine injection to confirm epidural anesthesia efficacy and safety. Epidural infusion of 0.15% ropivacaine (250mL) + fentanyl (2.5mg) via patient-controlled pump at 5mL/h with bolus option. Adjust infusion rate 1-3mL/h based on pain needs.

Procedure: Thoracic Epidural Analgesia

Interventions

Thoracic Epidural Analgesia PROCEDURE

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.

TEA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years old (inclusive).
• Admission within 7 days of onset of acute pancreatitis diagnosis.
• Admission to the ICU with single or multiple organ failure (lasting more than 48 hours).
• Voluntary participation in this study and signing of the informed consent form. If the subject is unable to read and sign the informed consent form due to lack of capacity, their legal guardian must participate in the informed consent process and sign the form on their behalf. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness must witness the informed consent process and sign the form.

You may not qualify if:

• Lactating or pregnant women, or those planning pregnancy within 6 months.
• Chronic pancreatitis or pancreatitis related to pancreatic tumors.
• Previously underwent surgical debridement and drainage.
• Previous cardiopulmonary resuscitation with no neurological recovery.
• History of severe primary cardiovascular, respiratory, renal, hepatic, hematologic, malignant tumor, or immune disease conditions: heart failure patients with New York Heart Association (NYHA) functional class greater than II; active myocardial ischemia undergoing cardiovascular intervention within 60 days.
• Allergy to local anesthetics.
• Anatomical variation preventing \"thoracic epidural blockade.\"
• Coagulation disorders or undergoing anticoagulant therapy.
• Participation in other interventional clinical studies in the past 3 months.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Tea

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

Study Officials

• hong yu

  sir run run shaw hospital，hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 25, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)