- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01964066
Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Volgograd, Russian Federation, 400079
- Clinic №1 of Volgograd State Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ERCP & Thoracic epidural analgesia
Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
|
Endoscopic retrograde cholangiopancreatography balloon dilatation
Other Names:
Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
Other Names:
|
ACTIVE_COMPARATOR: ERCP & Premedication
Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.
|
Endoscopic retrograde cholangiopancreatography balloon dilatation
Other Names:
For premedication used trimeperidine 2%-1ml intravenously.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the prevention of post-ERCP pancreatitis
Time Frame: one day
|
one day
|
Collaborators and Investigators
Investigators
- Study Chair: Mihail Turovets, PhD, Clinic №1 of Volgograd State Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 124/2007/12/24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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