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

Not Applicable

Completed

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Procedure: ERCP; Procedure: Thoracic epidural analgesia; Procedure: Premedication

• Registration Number: NCT01964066
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2013-03
• Study Completion: 2013-09
• Study First Submitted: 2013-09-17
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-13
• Study First Posted: 2013-10-17
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERCP & Premedication	ERCP	Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.
ERCP & Thoracic epidural analgesia	ERCP	Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
ERCP & Thoracic epidural analgesia	Thoracic epidural analgesia	Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
ERCP & Premedication	Premedication	Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.

Primary Outcome Measures

Name	Time	Method
the prevention of post-ERCP pancreatitis	one day

Trial Locations

Locations (1)

Clinic №1 of Volgograd State Medical University; 🇷🇺 Volgograd, Russian Federation