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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leo Buhler, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01607996
First received: May 22, 2012
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Severe Acute Pancreatitis
Procedure: Epidural anesthesia
Drug: Patient controlled intravenous analgesia
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter

  • Pancreatic perfusion measured by computerized tomography [ Time Frame: On day 0 and day 2 or 3 after hospital admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks ] [ Designated as safety issue: No ]
    Lenght of stay, admission to intensive care unit, need for surgery


Enrollment: 35
Study Start Date: July 2005
Study Completion Date: November 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 22, 2012
Last Updated: May 25, 2012
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014