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For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has been the most frequent adverse effect of endoscopic transpapillary interventions. We sought to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP pancreatitis.
Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491 patients was conducted. The first group of patients (N=247) received thoracic epidural analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a narcotic analgesic. To detect statistically significant differences between research groups adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.
Preoperatively the subjects were randomly assigned (by using sealed envelopes - blind randomization) into two groups, 250 patients each.
The patients of the first group had TEA applied during the ERCP procedure; other methods of pain relief were applied to the patients of the second (control) group.
The first group (TEA group) of patients received the following premedication: atropine sulfate 0.5-1 mg, midazolan 5 mg. The puncture and catheterization of the epidural space was carried out according to standard procedure between thoracic vertebrae VII-VIII. Half an hour before performing ERCP ropivacaine 0.5% -10 ml. was injected into the epidural space.
The second group (control group) of patients received the following premedication: atropine sulfate 0.5 -1 mg, midazolan 5 mg, trimeperidine 2% -1 ml.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERCP & Thoracic epidural analgesia | Experimental | Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP. |
|
| ERCP & Premedication | Active Comparator | Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP | Procedure | Endoscopic retrograde cholangiopancreatography balloon dilatation |
|
| Measure | Description | Time Frame |
|---|---|---|
| the prevention of post-ERCP pancreatitis | one day |
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Inclusion criteria:
Exclusion criteria:
- Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others).
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| Name | Affiliation | Role |
|---|---|---|
| Mihail Turovets, PhD | Clinic â„–1 of Volgograd state medical university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic â„–1 of Volgograd State Medical University | Volgograd | 400079 | Russia |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D013662 | Tea |
| D015360 | Analgesia, Epidural |
| D000767 | Anesthesia, Epidural |
| D011292 | Premedication |
| D058126 | Balanced Anesthesia |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| Thoracic epidural analgesia | Procedure | Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml) |
|
|
| Premedication | Procedure | For premedication used trimeperidine 2%-1ml intravenously. |
|
|
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000768 | Anesthesia, General |