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NCT Number: NCT01607996

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

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.

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Key information

Conditions

Severe Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural anesthesia

Procedure

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

Patient controlled intravenous analgesia

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
May 30, 2012
Registry last updated
May 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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