Pain ReliefeVUSCH/POPT1NCT03915301
Effective Postoperative Pain Treatment After Sternotomy. Comparison of the Erector Spinae Plane Block vs Conventional Opioid Treatment
An observational study of Pain Reliefe, run by Pavol Jozef Safarik University at 1 site in Slovakia.
Trial summary
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Reliefe
- What is being tested?
- Satisfaction assessed by the VAS [followed by its scale information in the Description]
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSlovakia
- Study dates
- 20 Jul 2020to 31 Dec 2020
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients after cardiac surgery
Who may be able to join
- Postoperative state after cardiac surgery, Serious pain NRS 8-10
Who cannot join
- disagreement
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
East Slovak Institute for Cardiovascular Diseases
Košice, 04011
Ladislav Kocan, MD PhD
About this study
Official title: VUSCH/PostOperativePainTreatment1
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery
Read the 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.
- Conditions
- Pain Reliefe
- Being tested
- Satisfaction assessed by the VAS [followed by its scale information in the Description]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satisfaction assessed by the VAS [followed by its scale information in the Description]Procedure or surgery
Erector spinae plane block provided in thoracic part of spine, VAS scale 0-10
| Study group | Role | What they receive |
|---|---|---|
| ESPB | Erector spinae plane block group Receives: Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description] | |
| Opioids | Opioid group Receives: Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with pain treatment assessed by the numerical rating scale VAS
Pain assessed by VAS 0-10 score
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start20 Jul 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ReliefeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Pavol Jozef Safarik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kočan Ladislav, Pavol Jozef Safarik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915301
- Sponsor's protocol ID
- 1/2019/VUSCH/EK
- Acronym
- VUSCH/POPT1
- Status last verified
- Jul 2019
- First submitted
- 8 Apr 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VUSCH/PostOperativePainTreatment1
- ClinicalTrials.gov ID
- NCT03915301
- Acronym / sponsor ID
- VUSCH/POPT1 / 1/2019/VUSCH/EK
- Conditions
- Pain Reliefe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pavol Jozef Safarik UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB | – | Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]Erector spinae plane block group |
| Opioids | – | Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]Opioid group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiac surgery
Key inclusion criteria (1 listed)
- Postoperative state after cardiac surgery, Serious pain NRS 8-10
Key exclusion criteria (1 listed)
- disagreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | ESPB, Opioids |
Primary outcome
Satisfaction with pain treatment assessed by the numerical rating scale VAS
Time frame: 12 hours
Pain assessed by VAS 0-10 score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Reliefe, run by Pavol Jozef Safarik University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ladislav Kočan, MD, PhD (00421907440250, lkocan@vusch.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with pain treatment assessed by the numerical rating scale VAS (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.