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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01607996
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : May 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Severe Acute Pancreatitis Procedure: Epidural anesthesia Drug: Patient controlled intravenous analgesia Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Study Start Date : July 2005
Primary Completion Date : August 2010
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Patient controlled intravenous analgesia
Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h
Drug: Patient controlled intravenous analgesia
Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour
Experimental: Epidural anesthesia
Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour
Procedure: 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


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with adverse events related to epidural anesthesia [ Time Frame: 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

  2. Pancreatic perfusion measured by computerized tomography [ Time Frame: On day 0 and day 2 or 3 after hospital admission ]

Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607996


Locations
Switzerland
University Hospital Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
More Information

Publications:
Responsible Party: Leo Buhler, Associate Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01607996     History of Changes
Other Study ID Numbers: HUG 02-0555
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Leo Buhler, University Hospital, Geneva:
Epidural anesthesia
pancreatic perfusion
pancreatic necrosectomy

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Anesthetics
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General