Erector Spinae Plane BlockNCT04420104
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
A study testing erector spinae plane block and iv analgesia in people with Erector Spinae Plane Block and Cardiac Surgery, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Erector Spinae Plane Block, Cardiac Surgery
- What is being tested?
- erector spinae plane block and iv analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jun 2021
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ASA score I-III
- Must be 18-75 years old
- must undergo cardiac surgery
Who cannot join
- emergency surgery,
- bleeding diathesis,
- presence of contraindications to LA agents used in this study,
- use of chronic opioids,
- psychiatric disorders.
- prolonged extubation
- presence of infection at the injection site.
- cardiovascular conditions (EF<40, LMCA obstruction)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Aydin, 09100
sinem sari, 090 4441256-2108, sarisinem@yahoo.com
Pelin Dilsiz
About this study
The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.
- Conditions
- Erector Spinae Plane Block, Cardiac Surgery
- Being tested
- erector spinae plane block, iv analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockProcedure or surgery
ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
iv analgesiaDrug
iv contromal
| Study group | Role | What they receive |
|---|---|---|
| esp block group | Experimental | Not described Receives: Procedure: erector spinae plane block; Drug: iv analgesia |
| control group | Active comparator | Not described Receives: Drug: iv analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.
The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline)
Measured: baseline and hours 3-6-12-24-36-48
time to mobilize the patient
time to mobilize the patient is reported as when the patient is mobilized
Measured: Any time for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
- Investigators
- Sinem Sari, Assoc Prof, Principal investigator, Adnan Menderes University Medical Faculty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420104
- Sponsor's protocol ID
- AMU
- Status last verified
- Jul 2020
- First submitted
- 3 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PubMed 30052229Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
PubMed 30055991
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04420104
- Acronym / sponsor ID
- AMU
- Conditions
- Erector Spinae Plane Block, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 9 Jun 2020 (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.
The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esp block group | Experimental | Procedure: erector spinae plane block, Drug: iv analgesia |
| control group | Active comparator | Drug: iv analgesia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be ASA score I-III
- Must be 18-75 years old
- must undergo cardiac surgery
Key exclusion criteria (8 listed)
- emergency surgery,
- bleeding diathesis,
- presence of contraindications to LA agents used in this study,
- use of chronic opioids,
- psychiatric disorders.
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 |
|---|---|---|
| erector spinae plane blockESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline. | Procedure or surgery | esp block group |
| iv analgesiaiv contromal | Drug | control group, esp block group |
Primary outcome
change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.
Time frame: baseline and hours 3-6-12-24-36-48
The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline)
time to mobilize the patient
Time frame: Any time for 7 days
time to mobilize the patient is reported as when the patient is mobilized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 30052229Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
- Background: PubMed 30055991Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
- Individual participant dataSharing planned: No
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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.
Sinem Sari, Assoc Prof principal investigator
Adnan Menderes University Medical Faculty Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae plane block and iv analgesia in people with Erector Spinae Plane Block and Cardiac Surgery, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 8 Jul 2020. 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 Turkey (Türkiye). 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 Sinem Sari, Assoc Prof (90 507 539 63 13, sarisinem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48. (time frame: baseline and hours 3-6-12-24-36-48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420104, which also lists 2 linked publications.
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 8 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.