Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis

Study Overview
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Brief Summary
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The aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.

Detailed Description
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High mortality in severe acute pancreatitis (AP) is linked to necrosis of the gland. Animal studies showed that epidural anesthesia (EA) restores pancreatic microcirculation and decreases the severity of AP. The aim of the study is to evaluate the safety of EA, its effect on pancreatic perfusion and clinical outcome of patients with AP.

Official Title
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Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis

Conditions
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Severe Acute Pancreatitis

Intervention / Treatment
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* Procedure: Epidural anesthesia
* Drug: Patient controlled intravenous analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute pancreatitis with Ranson Criteria over 2, and/or CRP over 100, and or pancreatic necrosis on CT scan Exclusion Criteria: Coagulation disorders Skin infection of the vertebral region

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient controlled intravenous analgesia<br>Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h | Drug: Patient controlled intravenous analgesia<br>* Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour<br>|
| Experimental: Epidural anesthesia<br>Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour | Procedure: Epidural anesthesia<br>* Epidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events related to epidural anesthesia | Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter | Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks | 
| Pancreatic perfusion measured by computerized tomography |  | On day 0 and day 2 or 3 after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Lenght of stay, admission to intensive care unit, need for surgery | Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural anesthesia, pancreatic perfusion, pancreatic necrosectomy