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Effective Postoperative Pain Treatment After Sternotomy. Comparison of the Erector Spinae Plane Block vs Conventional Opioid Treatment (VUSCH/POPT1)

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ClinicalTrials.gov Identifier: NCT03915301
Recruitment Status : Unknown
Verified July 2019 by Kočan Ladislav, Pavol Jozef Safarik University.
Recruitment status was:  Recruiting
First Posted : April 16, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kočan Ladislav, Pavol Jozef Safarik University

Study Description
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Brief Summary:
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery

Condition or disease Intervention/treatment
Pain Reliefe Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]

Detailed Description:
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery. In group "A" will be erector spinae plane block provided in the thoracic part of the body, under ultrasound control. In the group B will be analgesia provided by Pethidine. Numerical pain score will be recorded every 2 hours, also usage of analgetics will be recorded in both groups.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: VUSCH/PostOperativePainTreatment1
Estimated Study Start Date : July 20, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 31, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
ESPB
Erector spinae plane block group
 Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]
Erector spinae plane block provided in thoracic part of spine, VAS scale 0-10
Opioids
Opioid group
 Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]
Erector spinae plane block provided in thoracic part of spine, VAS scale 0-10


Outcome Measures
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Primary Outcome Measures :
  1. Satisfaction with pain treatment assessed by the numerical rating scale VAS [ Time Frame: 12 hours ]
    Pain assessed by VAS 0-10 score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients after cardiac surgery
Criteria

Inclusion Criteria:

  • Postoperative state after cardiac surgery, Serious pain NRS 8-10

Exclusion Criteria:

  • disagreement
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915301


Contacts
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Contact: Ladislav Kočan, MD, PhD 00421907440250 lkocan@vusch.sk

Locations
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Slovakia
East Slovak Institute for Cardiovascular Diseases Recruiting
Kosice, Slovakia, 04011
Contact: Ladislav Kocan, MD PhD         
Sponsors and Collaborators
Pavol Jozef Safarik University
More Information
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Responsible Party: Kočan Ladislav, Principal investigator, Pavol Jozef Safarik University
ClinicalTrials.gov Identifier: NCT03915301    
Other Study ID Numbers: 1/2019/VUSCH/EK
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No