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

University Hospitals (UH)

Status and phase: Completed; Phase 1

Conditions: Severe Acute Pancreatitis

Treatments: Drug: Patient controlled intravenous analgesia; Procedure: Epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01607996

HUG 02-0555

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Patient controlled intravenous analgesia

Active Comparator group

Description:

Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h

Treatment:

Drug: Patient controlled intravenous analgesia

Epidural anesthesia

Experimental group

Description:

Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour

Treatment:

Procedure: Epidural anesthesia