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

July 2, 2019 updated by: Kočan Ladislav, Pavol Jozef Safarik University

VUSCH/PostOperativePainTreatment1

Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Kosice, Slovakia, 04011
        • Recruiting
        • East Slovak Institute for Cardiovascular Diseases
        • Contact:
          • Ladislav Kočan, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients after cardiac surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • disagreement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with pain treatment assessed by the numerical rating scale VAS
Time Frame: 12 hours
Pain assessed by VAS 0-10 score
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pavol Jozef Safarik University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 20, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1/2019/VUSCH/EK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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