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Trial record 3 of 3 for:    "Acute Pancreatitis" | "Ropivacaine"

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

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ClinicalTrials.gov Identifier: NCT01964066
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Volgograd State Medical University

Tracking Information
First Submitted Date  ICMJE September 17, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date October 17, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2013)
the prevention of post-ERCP pancreatitis [ Time Frame: one day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Official Title  ICMJE Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Post-ERCP Acute Pancreatitis
Intervention  ICMJE
  • Procedure: ERCP
    Endoscopic retrograde cholangiopancreatography balloon dilatation
    Other Name: endoscopic transpapillary intervention
  • Procedure: Thoracic epidural analgesia
    Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
    Other Names:
    • Epidural analgesia
    • Epidural anaesthesia
  • Procedure: Premedication
    For premedication used trimeperidine 2%-1ml intravenously.
    Other Names:
    • anociassociation
    • anocithesia
    • prenarcosis
Study Arms  ICMJE
  • Experimental: ERCP & Thoracic epidural analgesia
    Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
    Interventions:
    • Procedure: ERCP
    • Procedure: Thoracic epidural analgesia
  • Active Comparator: ERCP & Premedication
    Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.
    Interventions:
    • Procedure: ERCP
    • Procedure: Premedication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2013)
491
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 92 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964066
Other Study ID Numbers  ICMJE 124/2007/12/24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Volgograd State Medical University
Study Sponsor  ICMJE Volgograd State Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mihail Turovets, PhD Clinic №1 of Volgograd state medical university
PRS Account Volgograd State Medical University
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP