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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01964066
Enrollment
491
Registered
2013-10-17
Start date
2008-01-31
Completion date
2013-09-30
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-ERCP Acute Pancreatitis

Keywords

therapeutic ERCP, prevention of post-ERCP pancreatitis, thoracic epidural analgesia

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.

Interventions

PROCEDUREERCP

Endoscopic retrograde cholangiopancreatography balloon dilatation

PROCEDUREThoracic epidural analgesia

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

PROCEDUREPremedication

For premedication used trimeperidine 2%-1ml intravenously.

Sponsors

Volgograd State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 92 Years
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).

Design outcomes

Primary

MeasureTime frame
the prevention of post-ERCP pancreatitisone day

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026