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

NCT ID: NCT01607996

Last Updated: 2012-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2011-11-30

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.

Conditions

Severe Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient controlled intravenous analgesia

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

Group Type: ACTIVE_COMPARATOR

Patient controlled intravenous analgesia

Intervention Type: DRUG

Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour

Epidural anesthesia

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

Group Type: EXPERIMENTAL

Epidural anesthesia

Intervention Type: PROCEDURE

Epidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour

Interventions

Epidural anesthesia

Epidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour

Intervention Type: PROCEDURE

Patient controlled intravenous analgesia

Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Leo Buhler

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

References

Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkamper AW, Guvener N, Mai G, Berney T, Frossard JL, Buhler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 Feb 14;12(6):915-20. doi: 10.3748/wjg.v12.i6.915.

Reference Type: BACKGROUND

PMID: 16521220 (View on PubMed)

Other Identifiers

HUG 02-0555

Identifier Type: -

Identifier Source: org_study_id