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Trial record 3 of 3 for:    "Acute Pancreatitis" | "Ropivacaine"

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

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ClinicalTrials.gov Identifier: NCT01964066
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Volgograd State Medical University

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.


Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Procedure: ERCP Procedure: Thoracic epidural analgesia Procedure: Premedication Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
Study Start Date : January 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ERCP & Thoracic epidural analgesia
Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
Procedure: ERCP
Endoscopic retrograde cholangiopancreatography balloon dilatation
Other Name: endoscopic transpapillary intervention

Procedure: Thoracic epidural analgesia
Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
Other Names:
  • Epidural analgesia
  • Epidural anaesthesia

Active Comparator: ERCP & Premedication
Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.
Procedure: ERCP
Endoscopic retrograde cholangiopancreatography balloon dilatation
Other Name: endoscopic transpapillary intervention

Procedure: Premedication
For premedication used trimeperidine 2%-1ml intravenously.
Other Names:
  • anociassociation
  • anocithesia
  • prenarcosis




Primary Outcome Measures :
  1. the prevention of post-ERCP pancreatitis [ Time Frame: one day ]


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Ages Eligible for Study:   15 Years to 92 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964066


Locations
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Russian Federation
Clinic №1 of Volgograd State Medical University
Volgograd, Russian Federation, 400079
Sponsors and Collaborators
Volgograd State Medical University
Investigators
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Study Chair: Mihail Turovets, PhD Clinic №1 of Volgograd state medical university

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Responsible Party: Volgograd State Medical University
ClinicalTrials.gov Identifier: NCT01964066     History of Changes
Other Study ID Numbers: 124/2007/12/24
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013
Keywords provided by Volgograd State Medical University:
therapeutic ERCP
prevention of post-ERCP pancreatitis
thoracic epidural analgesia
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases