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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01607996

Enrollment

Registered

2012-05-30

Start date

2005-07-31

Completion date

2011-11-30

Last updated

2012-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Pancreatitis

Keywords

Epidural anesthesia, pancreatic perfusion, pancreatic necrosectomy

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.

Interventions

PROCEDUREEpidural anesthesia

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

DRUGPatient controlled intravenous analgesia

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with adverse events related to epidural anesthesia	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
Pancreatic perfusion measured by computerized tomography	On day 0 and day 2 or 3 after hospital admission	—

Secondary

Measure	Time frame	Description
Clinical outcome	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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026