Erector Spinae Plane BlockPhase 3NCT07666178
Continuous ESP Block in Patients Undergoing CABG Surgery.
A Phase 3 study testing Ropivacaine and Standard Postoperative Analgesics in people with Erector Spinae Plane Block, run by Instituto do Coracao at 1 site in Brazil.
Trial summary
This study addresses articles and studies related to the erector spinae plane (ESP) block and its technique, advantages and disadvantages, applicability, among others. It aims to provide more information about this block, which is relatively new, and how it can be explored in the anesthesiologist's routine, mainly… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Erector Spinae Plane Block
- What is being tested?
- Ropivacaine and Standard Postoperative Analgesics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Dec 2024to 12 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consent to the free and informed consent term.
- Patient undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB).
- Preserved left ventricular global function (LVEF > 50%).
Who cannot join
- Moderate or severe valvular dysfunction.
- Previous anterior sternotomy.
- Known allergy to the study drugs.
- Complications during catheter insertion or block placement.
- Pre-existing diagnosed chronic pain under treatment.
- Concomitant use of drugs with a long half-life (induction and anesthetic maintenance doses will be standardized; patients taking medications with a long half-life are excluded to prevent bias in outcome assessment).
- Concomitant administration of Magnesium Sulfate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Continuous Erector Spinea Plane Block in Patients Undergoing Coronary Artery By-pass Graft Surgery.
This study addresses articles and studies related to the erector spinae plane (ESP) block and its technique, advantages and disadvantages, applicability, among others. It aims to provide more information about this block, which is relatively new, and how it can be explored in the anesthesiologist's routine, mainly inserted in the anesthesia scenario for cardiac surgery with a focus on postoperative analgesia.
Read the detailed description
All patients who meet the inclusion criteria will be submitted to ESP block after anesthetic induction. This will be performed with fentanyl (up to 5 micrograms/Kg), etomidate (2 milligrams/Kg) and cisatracurium at a dose of two DE95. Then the operator will perform the esp block, at the level of the fourth thoracic vertebra, being blinded as to the content of the solution, if local anesthetic (25 ml of 0.375% Ropivacaine in each side, respecting the toxic dose) or placebo (25 ml of 0.9% NaCl on each side). There will be randomization as to the inclusion in each group, using software. After puncture and infusion of the initial dose, a catheter (Contiplex C,Bbraun) will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding solution of ropivacaine or 0.9% NaCl programmed with a maintenance dose a 4ml / Hr and 06ml bolus with trigger. Anesthetic maintenance with halogenated (sevoflurane), cisatracurium in a continuous infusion pump (CIP) of 1-3 micrograms/Kg/min and if necessary remifentanil 0.1-0.3 microgram/Kg/min.
All patients will be submitted to the institution's standard management: multimodal analgesia with common analgesic (dipyrone 4 to 8 g / day or paracetamol 1500 to 2250 mg / day, tramadol 200 to 400 mg / day) in addition to rescue analgesia if necessary. (morphine 02 mg). PCA withdrawal will be on the fifth postoperative day .
- Conditions
- Erector Spinae Plane Block
- Being tested
- Ropivacaine, Standard Postoperative Analgesics, Placebo (0.9% Sodium Chloride)
- Keywords
- Spinae erector block, esp block, Analgesia, Continuous analgesia, block
- Medical subject headings
- Agnosia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Bilateral Erector Spinae Plane (ESP) block performed at the T4 level using 25 mL of 0.25% ropivacaine per side, followed by continuous postoperative patient-controlled regional analgesia (PCA) pump programmed with ropivacaine (maintenance rate of 4 mL/h, demand bolus of 6 mL).
Standard Postoperative AnalgesicsDrug
Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.
Placebo (0.9% Sodium Chloride)Drug
Inactive saline solution (25 mL of 0.9% NaCl per side) administered during a sham bilateral ESP block at the T4 level, followed by a continuous postoperative PCA pump infusion of 0.9% NaCl (maintenance rate of 4 mL/h, demand bolus of 6 mL) to serve as a comparator.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block Ropivacaine PCA group | Active comparator | Local anesthetic solution group that received the solution with the local anesthetic in the ESP block and also in the patient-controlled analgesia pump. Perform the esp block, at the level of the fourth thoracic vertebra, administration of local anesthetic (25 ml of 0.25% ropivacaine in each side, respecting the toxic dose).After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding bupivacaine solution programmed with a maintenance dose of 4ml / Hr and bolus of 06 ml with the trigger firing. Receives: Drug: Ropivacaine; Drug: Standard Postoperative Analgesics |
| ESP Block placebo PCA group | Placebo comparator | Group that will serve as a comparison for blockade with analgesia. That is, this group had received a placebo solution. Perform the esp block, at the level of the fourth thoracic vertebra, and the content of the solution will be placebo (25 ml of saline / 0.9% NaCl on each side). After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with 0.9% NaCl solution programmed with a maintenance dose at 4ml / Hr and 06 ml bolus with trigger. Receives: Drug: Standard Postoperative Analgesics; Drug: Placebo (0.9% Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Total cumulative consumption of morphine (measured in milligrams) recorded in the electronic medical record. All routes of administration (intravenous, patient-controlled analgesia pump, or oral) will be converted to intravenous morphine equivalents
Measured: From surgery completion up to postoperative day 5
Secondary outcomes (2)
Chronic pain scores at 30 days
Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
Measured: 30 days after intervention.
Chronic pain scores at 180 days
Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
Measured: 180 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start12 Dec 2024
- Primary completion12 Dec 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical, double-blinded, randomized, prospective trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666178
- Sponsor's protocol ID
- 29585120.1.0000.0068
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Erector Spinea Plane Block in Patients Undergoing Coronary Artery By-pass Graft Surgery.
- ClinicalTrials.gov ID
- NCT07666178
- Acronym / sponsor ID
- 29585120.1.0000.0068
- Conditions
- Erector Spinae Plane Block
- Keywords
- Spinae erector block, esp block, Analgesia, Continuous analgesia, block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
This study addresses articles and studies related to the erector spinae plane (ESP) block and its technique, advantages and disadvantages, applicability, among others. It aims to provide more information about this block, which is relatively new, and how it can be explored in the anesthesiologist's routine, mainly inserted in the anesthesia scenario for cardiac surgery with a focus on postoperative analgesia.
Detailed description
All patients who meet the inclusion criteria will be submitted to ESP block after anesthetic induction. This will be performed with fentanyl (up to 5 micrograms/Kg), etomidate (2 milligrams/Kg) and cisatracurium at a dose of two DE95. Then the operator will perform the esp block, at the level of the fourth thoracic vertebra, being blinded as to the content of the solution, if local anesthetic (25 ml of 0.375% Ropivacaine in each side, respecting the toxic dose) or placebo (25 ml of 0.9% NaCl on each side). There will be randomization as to the inclusion in each group, using software. After puncture and infusion of the initial dose, a catheter (Contiplex C,Bbraun) will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding solution of ropivacaine or 0.9% NaCl programmed with a maintenance dose a 4ml / Hr and 06ml bolus with trigger. Anesthetic maintenance with halogenated (sevoflurane), cisatracurium in a continuous infusion pump (CIP) of 1-3 micrograms/Kg/min and if necessary remifentanil 0.1-0.3 microgram/Kg/min.
All patients will be submitted to the institution's standard management: multimodal analgesia with common analgesic (dipyrone 4 to 8 g / day or paracetamol 1500 to 2250 mg / day, tramadol 200 to 400 mg / day) in addition to rescue analgesia if necessary. (morphine 02 mg). PCA withdrawal will be on the fifth postoperative day .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical, double-blinded, randomized, prospective trial
| Arm | Type | Receives |
|---|---|---|
| ESP Block Ropivacaine PCA group | Active comparator | Drug: Ropivacaine, Drug: Standard Postoperative AnalgesicsLocal anesthetic solution group that received the solution with the local anesthetic in the ESP block and also in the patient-controlled analgesia pump. Perform the esp block, at the level of the fourth thoracic vertebra, administration of local anesthetic (25 ml of 0.25% ropivacaine in each side, respecting the toxic dose).After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding bupivacaine solution programmed with a maintenance dose of 4ml / Hr and bolus of 06 ml with the trigger firing. |
| ESP Block placebo PCA group | Placebo comparator | Drug: Standard Postoperative Analgesics, Drug: Placebo (0.9% Sodium Chloride)Group that will serve as a comparison for blockade with analgesia. That is, this group had received a placebo solution. Perform the esp block, at the level of the fourth thoracic vertebra, and the content of the solution will be placebo (25 ml of saline / 0.9% NaCl on each side). After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with 0.9% NaCl solution programmed with a maintenance dose at 4ml / Hr and 06 ml bolus with trigger. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Consent to the free and informed consent term.
- Patient undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB).
- Preserved left ventricular global function (LVEF > 50%).
Key exclusion criteria (7 listed)
- Moderate or severe valvular dysfunction.
- Previous anterior sternotomy.
- Known allergy to the study drugs.
- Complications during catheter insertion or block placement.
- Pre-existing diagnosed chronic pain under treatment.
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 |
|---|---|---|
| RopivacaineBilateral Erector Spinae Plane (ESP) block performed at the T4 level using 25 mL of 0.25% ropivacaine per side, followed by continuous postoperative patient-controlled regional analgesia (PCA) pump programmed with ropivacaine (maintenance rate of 4 mL/h, demand bolus of 6 mL). | Drug | ESP Block Ropivacaine PCA group |
| Standard Postoperative AnalgesicsSystemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care. | Drug | ESP Block Ropivacaine PCA group, ESP Block placebo PCA group |
| Placebo (0.9% Sodium Chloride)Inactive saline solution (25 mL of 0.9% NaCl per side) administered during a sham bilateral ESP block at the T4 level, followed by a continuous postoperative PCA pump infusion of 0.9% NaCl (maintenance rate of 4 mL/h, demand bolus of 6 mL) to serve as a comparator. | Drug | ESP Block placebo PCA group |
Primary outcome
Total morphine consumption
Time frame: From surgery completion up to postoperative day 5
Total cumulative consumption of morphine (measured in milligrams) recorded in the electronic medical record. All routes of administration (intravenous, patient-controlled analgesia pump, or oral) will be converted to intravenous morphine equivalents
2 secondary outcomes
Chronic pain scores at 30 days
Time frame: 30 days after intervention.
Chronic pain scores at 180 days
Time frame: 180 days after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Erector Spinae Plane Block
Not yet recruiting
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
Single-level Lumbar Arthrodesis
Active, not recruiting
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
Analgesia
Active, not recruiting
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
Acut Postoperative Pain, Erector Spinae Plane Block
RecruitingPhase 1
ESP Blocks in Breast Free Flaps
Breast Reconstruction, Free Flap Reconstruction
Not yet recruitingPhase 4
Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery
Adolescent Idiopathic Scoliosis (AIS)
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.
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 and Standard Postoperative Analgesics in people with Erector Spinae Plane Block, 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JOAO ALBERTO PASTOR de OLIVEIRA, MD (+5511991700431, joaoalbertopastor@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: From surgery completion up to postoperative day 5). 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 24 Jun 2026.