NCT01964066

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Volgograd State Medical University · Academic / Other
• Sex: All
• Age: 15 Years – 92 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	ERCP	Endoscopic retrograde cholangiopancreatography balloon dilatation
PROCEDURE	Thoracic epidural analgesia	Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
PROCEDURE	Premedication	For premedication used trimeperidine 2%-1ml intravenously.

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-03-01
• Completion: 2013-09-01
• First posted: 2013-10-17
• Last updated: 2020-10-19

Locations

1 site across 1 country: Russia