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
-
-
-
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
|
Erector spinae plane block provided in thoracic part of spine, VAS scale 0-10
|
|
Opioids
Opioid group
|
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
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.