Back to resultsEffect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Primary Purpose
Severe Acute Pancreatitis
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Epidural anesthesia
Patient controlled intravenous analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Pancreatitis focused on measuring Epidural anesthesia, pancreatic perfusion, pancreatic necrosectomy
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
Sites / Locations
- University Hospital Geneva
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Patient controlled intravenous analgesia
Epidural anesthesia
Arm Description
Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h
Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour
Outcomes
Primary Outcome Measures
Number of patients with adverse events related to epidural anesthesia
Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter
Pancreatic perfusion measured by computerized tomography
Secondary Outcome Measures
Clinical outcome
Lenght of stay, admission to intensive care unit, need for surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01607996
Brief Title
Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Official Title
Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Pancreatitis
Keywords
Epidural anesthesia, pancreatic perfusion, pancreatic necrosectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient controlled intravenous analgesia
Arm Type
Active Comparator
Arm Description
Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h
Arm Title
Epidural anesthesia
Arm Type
Experimental
Arm Description
Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour
Intervention Type
Procedure
Intervention Name(s)
Epidural anesthesia
Intervention Description
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
Drug
Intervention Name(s)
Patient controlled intravenous analgesia
Intervention Description
Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour
Primary Outcome Measure Information:
Title
Number of patients with adverse events related to epidural anesthesia
Description
Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Title
Pancreatic perfusion measured by computerized tomography
Time Frame
On day 0 and day 2 or 3 after hospital admission
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
Lenght of stay, admission to intensive care unit, need for surgery
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
16521220
Citation
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.
Results Reference
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Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
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