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Clinical Trials/NCT01964066
NCT01964066CompletedNot Applicable

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

Volgograd State Medical University2 sites in 1 country491 target enrollmentStarted: January 1, 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
491
Locations
2
Primary Endpoint
the prevention of post-ERCP pancreatitis

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
15 Years to 92 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

the prevention of post-ERCP pancreatitis

Time Frame: one day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Volgograd State Medical University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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