Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Primary Purpose
Post-ERCP Acute Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
ERCP
Thoracic epidural analgesia
Premedication
Sponsored by
About this trial
This is an interventional prevention trial for Post-ERCP Acute Pancreatitis focused on measuring therapeutic ERCP, prevention of post-ERCP pancreatitis, thoracic epidural analgesia
Eligibility Criteria
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).
Sites / Locations
- Clinic №1 of Volgograd State Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ERCP & Thoracic epidural analgesia
ERCP & Premedication
Arm Description
Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.
Outcomes
Primary Outcome Measures
the prevention of post-ERCP pancreatitis
Secondary Outcome Measures
Full Information
NCT ID
NCT01964066
First Posted
September 17, 2013
Last Updated
October 15, 2020
Sponsor
Volgograd State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01964066
Brief Title
Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Official Title
Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Volgograd State Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis
Keywords
therapeutic ERCP, prevention of post-ERCP pancreatitis, thoracic epidural analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
491 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERCP & Thoracic epidural analgesia
Arm Type
Experimental
Arm Description
Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
Arm Title
ERCP & Premedication
Arm Type
Active Comparator
Arm Description
Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.
Intervention Type
Procedure
Intervention Name(s)
ERCP
Other Intervention Name(s)
endoscopic transpapillary intervention
Intervention Description
Endoscopic retrograde cholangiopancreatography balloon dilatation
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural analgesia
Other Intervention Name(s)
Epidural analgesia, Epidural anaesthesia
Intervention Description
Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
Intervention Type
Procedure
Intervention Name(s)
Premedication
Other Intervention Name(s)
anociassociation, anocithesia, prenarcosis
Intervention Description
For premedication used trimeperidine 2%-1ml intravenously.
Primary Outcome Measure Information:
Title
the prevention of post-ERCP pancreatitis
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihail Turovets, PhD
Organizational Affiliation
Clinic №1 of Volgograd state medical university
Official's Role
Study Chair
Facility Information:
Facility Name
Clinic №1 of Volgograd State Medical University
City
Volgograd
ZIP/Postal Code
400079
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
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