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Thoracic epidural analgesia in patients with acute pancreatitis: a prospective, multicenter, randomized, parallel-controlled clinical study

Thoracic epidural analgesia in patients with acute pancreatitis: a prospective, multicenter, randomized, parallel-controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077448
Enrollment
Unknown
Registered
2023-11-09
Start date
2023-11-09
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Interventions

Control Group:Standard treatment
Thoracic Epidural Analgesia Group:Thoracic epidural analgesia on top of standard treatment

Sponsors

Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1)Age between 18 and 70 years (including borderline values). 2)Patients admitted to the hospital within 7 days of onset with a diagnosis of acute pancreatitis. 3)Admitted to ICU with single or multiple organ failure. 4)ASA class 1-III. 5)Voluntarily participate in this study and sign the informed consent form. If the subject is incapable of reading and signing the informed consent form for reasons such as incapacitation, his/her guardian will be required to act on his/her behalf in the informed process and sign the informed consent form. If the subject cannot read the informed consent form (e.g., illiterate subjects), a witness will be required to witness the informed process and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1)Patients who are breastfeeding and pregnant, or planning pregnancy within 6 months. 2)Patients with recurrent acute pancreatitis, chronic pancreatitis or pancreatic tumor-related pancreatitis. 3)Patients who have undergone surgical drainage and debridement and need emergency ERCP treatment. 4)Patients who have previously undergone cardiopulmonary resuscitation and have not recovered neurological function. 5)Patients with a history of severe cardiovascular, respiratory, renal, hepatic, hematologic, malignant neoplasm or immune diseases: patients with heart failure greater than NYHA Cardiac Function Class II; active myocardial ischemia within 60 days of cardiovascular intervention; history of cirrhosis; patients with chronic renal disease, creatinine clearance <40 mL/min; chronic obstructive pulmonary disease requiring home oxygen therapy. 6)Local anesthetic drug allergy. 7) anatomical variations, unable to perform "thoracic epidural analgesia". 8)Coagulation disorders or those who are on anticoagulation therapy. 9)Participation in other interventional clinical studies in the last 3 months. 10) Other conditions that, in the judgment of the investigator, make them unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Changes in the profile of systemic inflammatory response syndrome and organ dysfunction after inclusion;intra-abdominal pressure;Rest pain and motion pain;

Secondary

MeasureTime frame
Indicators of peripheral blood inflammation and immunity;Intestinal Microbiota;Total ICU treatment time;Patient treatment costs;vital signs;Incidence, timing and location of hemorrhages requiring interventional treatment;Incidence, timing and location of gastrointestinal perforations or fistulas requiring interventional treatment;Incidence of other adverse events;

Countries

China

Contacts

Public ContactHong Yu

Run Run Shaw Hospital, Zhejiang University School of Medicine

blueyu000@zju.edu.cn+86 136 0570 5907

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026