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

Phase 1

Completed

• Conditions: Severe Acute Pancreatitis
• Interventions: Drug: Patient controlled intravenous analgesia; Procedure: Epidural anesthesia

• Registration Number: NCT01607996
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2010-08
• Study Completion: 2011-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-25
• Last Update Submitted: 2012-05-25
• Study First Posted: 2012-05-30
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient controlled intravenous analgesia	Patient controlled intravenous analgesia	Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h
Epidural anesthesia	Epidural anesthesia	Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical outcome	Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks	Lenght of stay, admission to intensive care unit, need for surgery

Trial Locations

Locations (1)

University Hospital Geneva; 🇨🇭 Geneva, Switzerland