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

NCT01964066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 491

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

PROCEDURE

ERCP

Endoscopic retrograde cholangiopancreatography balloon dilatation

PROCEDURE

Thoracic epidural analgesia

Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)

PROCEDURE

Premedication

For premedication used trimeperidine 2%-1ml intravenously.

Sponsors & Collaborators

  • Volgograd State Medical University

    lead OTHER

Principal Investigators

  • Mihail Turovets, PhD · Clinic №1 of Volgograd state medical university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
92 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2013-03-31
Completion
2013-09-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01964066 on ClinicalTrials.gov