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

October 15, 2020 updated by: Volgograd State Medical University

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

Completed

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

Interventional

Enrollment (Actual)

491

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Volgograd, Russian Federation, 400079
        • Clinic №1 of Volgograd State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 92 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: ERCP
Endoscopic retrograde cholangiopancreatography balloon dilatation
Other Names:
  • 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 Names:
  • endoscopic transpapillary intervention
Procedure: Premedication
For premedication used trimeperidine 2%-1ml intravenously.
Other Names:
  • anociassociation
  • anocithesia
  • prenarcosis

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

This is where you will find people and organizations involved with this study.

Sponsor

Volgograd State Medical University

Investigators

  • Study Chair: Mihail Turovets, PhD, Clinic №1 of Volgograd State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

October 13, 2013

First Posted (ESTIMATE)

October 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

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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