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

Severe Acute Pancreatitis Clinical Trial

Official title:

Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607996
• Other study ID #: HUG 02-0555
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2012
• Last updated: May 25, 2012
• Start date: July 2005
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis
• Severe Acute Pancreatitis

Intervention

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

Drug:
• Patient controlled intravenous analgesia
Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkämper AW, Güvener N, Mai G, Berney T, Frossard JL, Bühler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 Feb 14;12(6):915-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events related to epidural anesthesia	Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter	Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks	Yes
Primary	Pancreatic perfusion measured by computerized tomography		On day 0 and day 2 or 3 after hospital admission	No
Secondary	Clinical outcome	Lenght of stay, admission to intensive care unit, need for surgery	Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks	No