Skip to main content
OpenTrials
Completed

NCT Number: NCT01964066

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-ERCP Acute Pancreatitis

Age range

15 year–92 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic №1 of Volgograd State Medical University

Volgograd, 400079, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ERCP

Procedure

Endoscopic retrograde cholangiopancreatography balloon dilatation

Other names: endoscopic transpapillary intervention

Thoracic epidural analgesia

Procedure

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

Other names: Epidural analgesia, Epidural anaesthesia

Premedication

Procedure

For premedication used trimeperidine 2%-1ml intravenously.

Other names: anociassociation, anocithesia, prenarcosis

Primary outcomes

  1. the prevention of post-ERCP pancreatitis

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Volgograd State Medical University

Other

Registry information

Official study title

Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2013
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.