Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Procedure: ERCP
* Procedure: Thoracic epidural analgesia
* Procedure: Premedication


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with performed therapeutic ERCP; The ERCP procedure was performed in a patient for the first time; Prior to the ERCP procedure the patient didn't have any clinical signs of acute pancreatitis. Exclusion criteria: - Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 92 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERCP & Thoracic epidural analgesia<br>Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP. | Procedure: ERCP<br>* Endoscopic retrograde cholangiopancreatography balloon dilatation<br>* Other names: endoscopic transpapillary intervention;Procedure: Thoracic epidural analgesia<br>* Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)<br>* Other names: Epidural anaesthesia;|
| Active Comparator: ERCP & Premedication<br>Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP. | Procedure: ERCP<br>* Endoscopic retrograde cholangiopancreatography balloon dilatation<br>* Other names: endoscopic transpapillary intervention;Procedure: Premedication<br>* For premedication used trimeperidine 2%-1ml intravenously.<br>* Other names: prenarcosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevention of post-ERCP pancreatitis |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic ERCP, prevention of post-ERCP pancreatitis, thoracic epidural analgesia