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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

491 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ERCP & Thoracic epidural analgesia

Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.

Group Type EXPERIMENTAL

ERCP

Intervention Type PROCEDURE

Endoscopic retrograde cholangiopancreatography balloon dilatation

Thoracic epidural analgesia

Intervention Type PROCEDURE

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

ERCP & Premedication

Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.

Group Type ACTIVE_COMPARATOR

ERCP

Intervention Type PROCEDURE

Endoscopic retrograde cholangiopancreatography balloon dilatation

Premedication

Intervention Type PROCEDURE

For premedication used trimeperidine 2%-1ml intravenously.

Interventions

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ERCP

Endoscopic retrograde cholangiopancreatography balloon dilatation

Intervention Type PROCEDURE

Thoracic epidural analgesia

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

Intervention Type PROCEDURE

Premedication

For premedication used trimeperidine 2%-1ml intravenously.

Intervention Type PROCEDURE

Other Intervention Names

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endoscopic transpapillary intervention Epidural analgesia Epidural anaesthesia anociassociation anocithesia prenarcosis

Eligibility Criteria

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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).

Minimum Eligible Age

15 Years

Maximum Eligible Age

92 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No