Spine ErectorPhase 3COESPINENCT04313959
Comparison Erect Spine in Cardiac Surgery
A Phase 3 study testing Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% + Dexamethasone in people with Spine Erector and Cardiac Surgery, run by Instituto do Coracao at 1 site in Brazil.
Trial summary
Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Erector, Cardiac Surgery, Acute Pain
- What is being tested?
- Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% + Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jan 2022to 17 Apr 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery bypass graft with cardiopulmonary bypass
- Left ventricular ejection fraction ≥ 45%
Who cannot join
- Reoperation
- Low cardiac output syndrome
- Preoperative coagulopathy
- Presence of ventricular assist device other than intraaortic ballon pump
- Emergency procedures
- Bacterial or fungal infection in the preceding 30 days
Show all 11Show fewer
- Active neoplasia
- Allergy or intolerance to steroids
- Allergy to ropivacaine
- Patient refusal
- Participation in other study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Incor - Heart Institute - University of Sao Paulo
São Paulo, 05403000
Filomena RG Galas, +551126615232, filomenagalas@hotmail.com
About this study
Official title: Comparison of Two Anesthetic Techniques in Blocking the Erector Plane of the Spine Bilateral in Cardiac Surgery: a Prospective Randomized Double-blinded Clinical Trial
Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be published. however, there is not enough data to convince the scientific community of its advantages, continuing to carry out its performance due to lack of evidence. Dexamethasone also shows an excellent result blocking the inflammatory chain and it was evidenced that it prolongs the time of blockages when used perineurally in the plexus blockages. This study wants to show the improvement of pain in patients who undergo this type of surgery and also show the advantages of a longer blockage, which can reduce use of analgesic and opioids, as well as decrease the time of hospitalization This is a double-blinded, randomized, clinical trial designed to determine the efficacy of spine erector whit dexamethasone gives more duration of the blockage and less pain after cardiac surgery.
Read the detailed description
Evaluation of acute pain pos cardiac surgery in patients that who were subjected at myocardial revascularization. We offer Espine erector block (ESP) with linear array Transducer and needle 100mm bilateral as a technique that offer results more hopeful and less invasive in patients with open cardiac surgery. Favoring the implementation of Fastrack anesthesia techniques in cardiac surgery and minimizing complications in this group of patients
- Conditions
- Spine Erector, Cardiac Surgery, Acute Pain, Chronic Pain
- Being tested
- Ropivacaine 0.2% Injectable Solution, Ropivacaine 0.2% + Dexamethasone
- Keywords
- Spine erector, Cardiac surgery, Coronary arterial bypass surgery, Acute Pain, Ropivacaine, Dexamethasone
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Also called Do not have
Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine
Ropivacaine 0.2% + DexamethasoneDrug
Also called Do not have
Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetic | Active comparator | Patients assigned for local anesthetic group will receive a single-shot ultrasound-guided erector spine plane block with 25 mL of 0.2% of ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Local anesthetic + steroid | Active comparator | Patients assigned for local anesthetic + steroid group will receive a single-shot ultrasound-guided erector spine block plane with 25 mL of 0.2% of ropivacaine with 5 mg dexamethasone Receives: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Ropivacaine 0.2% + Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity score
Changes in Numeric Rating Scale (NRS) and visual analogue scale (VAS) will be recorded daily at postoperative 1 to 7 day or until the patient's hospital discharge if this occurs before 7 days.
- Numerical rating scales A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
- VAS have also been utilized in EMA research. VAS are measures of subjective or behavioral experience (e.g., pain, physical exercise). They are typically presented as a 10 cm line with descriptive anchors at each end, such as "completed all prescribed activities today" to "completed none of the prescribed activities today." Respondents place a vertical line through the point on the scale that best fits their experience with that construct at that moment.
Measured: Within 7 days after cardiac surgery
Secondary outcomes (3)
Total opioids consumption
The total amount of opioids given by patient
Measured: Up to 2 postoperative day
Pain intensity score
Changes inThe Brief Pain Inventory (BPI).will be recorded after discharge at 30 days, 60 days and 90 days after surgery
*The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning; BPI Pain Items, Least pain in last 24 hours, Pain on average, Pain right now, Worst pain in last 24 hours; BPI Interference Items, Mood, Walking ability, Normal work (including housework), General activity, Relations with other people, Sleep, Enjoyment of life
Measured: Up to 90 days
Duration of mechanical ventilation
Duration in hours from the intraoperative intubation up to postoperative extubation
Measured: Within 7 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start20 Jan 2022
- Primary completion25 Feb 2023 (estimated)
- Study completion17 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spine ErectorStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Filomena R B G Galas, Instituto do Coracao
- Investigators
- Luis Alberto Rodriguez Linares, MD, Principal investigator, INCOR FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313959
- Sponsor's protocol ID
- 27166919.3.0000.0068
- Acronym
- COESPINE
- Status last verified
- Jul 2022
- First submitted
- 17 Mar 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Linares LAR, Martinez RCR, Carvalho VH, Navarro E Lima LH, Zeferino SP, Carneiro JO, Galas FRBG. Perineural dexamethasone as an adjuvant to erector spinae plane block for acute and chronic pain after cardiac surgery. Sci Rep. 2026 Jun 4. doi: 10.1038/s41598-026-55409-9. Online ahead of print.
PubMed 42243419
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Anesthetic Techniques in Blocking the Erector Plane of the Spine Bilateral in Cardiac Surgery: a Prospective Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04313959
- Acronym / sponsor ID
- COESPINE / 27166919.3.0000.0068
- Conditions
- Spine Erector, Cardiac Surgery, Acute Pain, Chronic Pain
- Keywords
- Spine erector, Cardiac surgery, Coronary arterial bypass surgery, Acute Pain, Ropivacaine, Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 25 Feb 2023 (estimated)
- Study completion
- 17 Apr 2023 (estimated)
- First posted
- 18 Mar 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.
Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be published. however, there is not enough data to convince the scientific community of its advantages, continuing to carry out its performance due to lack of evidence. Dexamethasone also shows an excellent result blocking the inflammatory chain and it was evidenced that it prolongs the time of blockages when used perineurally in the plexus blockages. This study wants to show the improvement of pain in patients who undergo this type of surgery and also show the advantages of a longer blockage, which can reduce use of analgesic and opioids, as well as decrease the time of hospitalization This is a double-blinded, randomized, clinical trial designed to determine the efficacy of spine erector whit dexamethasone gives more duration of the blockage and less pain after cardiac surgery.
Detailed description
Evaluation of acute pain pos cardiac surgery in patients that who were subjected at myocardial revascularization. We offer Espine erector block (ESP) with linear array Transducer and needle 100mm bilateral as a technique that offer results more hopeful and less invasive in patients with open cardiac surgery. Favoring the implementation of Fastrack anesthesia techniques in cardiac surgery and minimizing complications in this group of patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthetic | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionPatients assigned for local anesthetic group will receive a single-shot ultrasound-guided erector spine plane block with 25 mL of 0.2% of ropivacaine |
| Local anesthetic + steroid | Active comparator | Drug: Ropivacaine 0.2% Injectable Solution, Drug: Ropivacaine 0.2% + DexamethasonePatients assigned for local anesthetic + steroid group will receive a single-shot ultrasound-guided erector spine block plane with 25 mL of 0.2% of ropivacaine with 5 mg dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary artery bypass graft with cardiopulmonary bypass
- Left ventricular ejection fraction ≥ 45%
Key exclusion criteria (11 listed)
- Reoperation
- Low cardiac output syndrome
- Preoperative coagulopathy
- Presence of ventricular assist device other than intraaortic ballon pump
- Emergency procedures
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 |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionAlso: Do not haveSingle-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine | Drug | Local anesthetic, Local anesthetic + steroid |
| Ropivacaine 0.2% + DexamethasoneAlso: Do not haveAddiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution | Drug | Local anesthetic + steroid |
Primary outcome
Pain intensity score
Time frame: Within 7 days after cardiac surgery
Changes in Numeric Rating Scale (NRS) and visual analogue scale (VAS) will be recorded daily at postoperative 1 to 7 day or until the patient's hospital discharge if this occurs before 7 days. * Numerical rating scales A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable * VAS have also been utilized in EMA research. VAS are measures of subjective or behavioral experience (e.g., pain, physical exercise). They are typically presented as a 10 cm line with descriptive anchors at each end, such as "completed all prescribed activities today" to "completed none of the prescribed activities today." Respondents place a vertical line through the point on the scale that best fits their experience with that construct at that moment.
3 secondary outcomes
Total opioids consumption
Time frame: Up to 2 postoperative day
Pain intensity score
Time frame: Up to 90 days
Duration of mechanical ventilation
Time frame: Within 7 days after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 42243419Linares LAR, Martinez RCR, Carvalho VH, Navarro E Lima LH, Zeferino SP, Carneiro JO, Galas FRBG. Perineural dexamethasone as an adjuvant to erector spinae plane block for acute and chronic pain after cardiac surgery. Sci Rep. 2026 Jun 4. doi: 10.1038/s41598-026-55409-9. Online ahead of print.
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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.
Luis Alberto Rodriguez Linares, MD principal investigator
INCOR FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% + Dexamethasone in people with Spine Erector and Cardiac Surgery, run by Instituto do Coracao at 1 site in Brazil.
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 2 inclusion and 11 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 18 Jul 2022. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Luis Alberto Rodriguez Linares, MD (+55 11944450729, luis.linares@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity score (time frame: Within 7 days after cardiac surgery). 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 NCT04313959, which also lists 1 linked publication.
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 18 Jul 2022.