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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient controlled intravenous analgesia | Active Comparator | Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h |
|
| Epidural anesthesia | Experimental | Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pancreatic perfusion measured by computerized tomography | On day 0 and day 2 or 3 after hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Geneva | Geneva | Canton of Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16521220 | Background | 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. |
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| Patient controlled intravenous analgesia | Drug | Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour |
|
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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