Cadiac SurgeryPhase 2ESB-SternoNCT05160298
Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery
A Phase 2 study testing Ropivacaine 0,2% Injectable Solution in people with Cadiac Surgery and Median Sternotomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Cadiac Surgery, Median Sternotomy, Regional Anesthesia
- What is being tested?
- Ropivacaine 0,2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2021to 20 Dec 2022
- Phase
- Phase 2
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo scheduled cardiac surgery with sternotomy for aortic or mitral valve replacement either by biological or mechanical prothesis, coronary arterial bypass surgery (CABG).
- Body Mass Index between 18,5 and 33kg/m² (extremity excluded)
- Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code
- Possession of Social Security insurance
Who cannot join
- Emergency surgery
- Approach by thoracotomy
- Heart transplant
- Aortic dissection or chirurgical act on ascending thoracic Aorta
- Redo surgery.
- Pregnant women
Show all 16Show fewer
- Protected minors or adults
- Pre-existing psychiatric pathology including known states of opioid addiction
- Long-term opioid medication (>1month)
- Physical or intellectual inability to use a PCA
- Severe heart failure (ejection fraction less than 40% or PAH > 50 mmHg)
- Preoperative cardiogenic shock
- Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula
- Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).
- Known allergy or hypersensitivity to any of excipients of the study drugs or analgesia protocol
- Refusal of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery
The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy
Read the detailed description
Background:
Pain after cardiac surgery is mostly localized at the sternotomy site. To improve postoperative pain management a number of technics involving loco-regional anesthesia have been developed. The epidural analgesia is the gold standard but the risk of epidural hematoma with heparinization in this surgery avoids its utilization in clinical practice. The paravertebral block can be used equally but there is a risk of pneumothorax. The erector spinae plane block could be a solution as it is a more superficial block. It's efficacity was proven in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. A bilateral erector spinae plane block after cardiac surgery could significantly reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction.
The main objective of this to study is to examine the efficacity of a single-shot bilateral erector spinae plane block on pain reduction during mobilization during the first 48 hours after cardiac surgery compared to a control group.
The primary outcome:
Pain scale at patient mobilization during the first postoperative 48 hours measured by numerical pain scale.
Study design:
Prospective, randomized, doubled-blinded, single-center controlled trial with two groups:
- The ropivacaine group (42 patients): a bilateral erector spinae block will be performed after patient arrival in the intensive care unit before wake up from anesthesia with 20ml of Ropivacaine 2mg/ml bilaterally.
- The control group (42 patients): a sham block will be performed bilaterally in the same conditions.
- Being tested
- Ropivacaine 0,2% Injectable Solution, Control group
- Keywords
- Postoperative analgesia, Erector spinae plane block, Local anesthetics, Ropivacaine, Sternotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0,2% Injectable SolutionDrug
Echo-guided bilateral erector spinae block
Control groupOther
Sham block
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine group | Experimental | Performance of an echo-guided bilateral erector spinae block at the arrival in the intensive care unit with 20ml of Ropivacaine 2mg/ml in each side. Receives: Drug: Ropivacaine 0,2% Injectable Solution |
| Control group | Sham comparator | Performance of a sham block at the arrival in the intensive care unit with no drugs administration Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain score during cough
Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough
Measured: From patient awakening to 48 hours later (one evalution every 4 hours)
Secondary outcomes (18)
Change of pain score during patient tourn in the bed (lateralization) for nursing
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Measured: From patient awakening to 48 hours later (one evalution every 4 hours)
Change of pain score during central venous pressure measuring
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Measured: From patient awakening to 48 hours later (one evalution every 4 hours)
Change of sternal pain score at rest
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Measured: From patient awakening to 48 hours later (one evalution every 4 hours)
Change of dorsal pain evaluation at rest
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Measured: From patient awakening to 48 hours later (one evalution every 4 hours)
Opioid consumption
Total opioid consumption since the awakening of the patient during 48 postoperative hours.
Measured: 48 hours after intervention
Satisfaction assessed by the Likert scale
Subjective Assessment of pain management by the patient on a Likert scale going from 0 to 4 where 4 is excellent
Measured: 48 hours after intervention
Spirometry measure of forced vital capacity (FVC)
Assessment of the change of FVC by repeating spirometry during the hospital stay
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of forced expiratory volume in one second (FEV1)
Assessment of the change of FEV1 by repeating spirometry during the hospital stay
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of FEV1/FVC
Assessment of the change of FEV1/FVC by repeating spirometry during the hospital stay
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of peak expiratory flow (PEF)
Assessment of the change of PEF by repeating spirometry during the hospital stay
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75%
Assessment of the change of FEF 25%, FEF 50%, FEF 75%, FEF 25-75% by repeating spirometry during the hospital stay
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragmatic excursion
Assessment of the diaphragmatic excursion by repeating diaphragm echography during the hospital stay
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragm thickness
Assessment of the diaphragmatic thickness by repeating diaphragm echography during the hospital stay
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragm thickening fraction
Assessment of the diaphragmatic thickening fraction (%) by repeating diaphragm echography during the hospital stay
Measured: Up to 6 months after surgery (end of Hospital stay)
Digestive function
Time of recovery of normal bowel function. Beginning of oral feeding
Measured: The day before surgery, the first or second day after surgery and the seventh day after surgery
Digestive function
Time of recovery of normal bowel function.. Incidence of postoperative nausea and vomiting
Measured: Up to 6 months after surgery (end of Hospital stay)
Time of drain removal
Time when the drain are removed of the patient
Time when the drain are removed of the patient
Measured: Up to 6 months after surgery (end of Hospital stay)
Postoperative complications
occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications
Measured: Up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start20 Oct 2021
- Primary completion20 Nov 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cadiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * The ropivacaine group (42 patients): Echo-guided bilateral erector spinae block at the arrival in the intensive care unit. 20ml of Ropivacaine 2mg/ml for each side. * The control group (42 patients): Sham block bilaterally.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vedat Eljezi, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160298
- Sponsor's protocol ID
- ESB-Sterno (RBHP2021ELJEZI)
- Acronym
- ESB-Sterno
- Status last verified
- Jul 2023
- First submitted
- 18 Oct 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05160298
- Acronym / sponsor ID
- ESB-Sterno / ESB-Sterno (RBHP2021ELJEZI)
- Keywords
- Postoperative analgesia, Erector spinae plane block, Local anesthetics, Ropivacaine, Sternotomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 16 Dec 2021 (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 sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy
Detailed description
Background:
Pain after cardiac surgery is mostly localized at the sternotomy site. To improve postoperative pain management a number of technics involving loco-regional anesthesia have been developed. The epidural analgesia is the gold standard but the risk of epidural hematoma with heparinization in this surgery avoids its utilization in clinical practice. The paravertebral block can be used equally but there is a risk of pneumothorax. The erector spinae plane block could be a solution as it is a more superficial block. It's efficacity was proven in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. A bilateral erector spinae plane block after cardiac surgery could significantly reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction.
The main objective of this to study is to examine the efficacity of a single-shot bilateral erector spinae plane block on pain reduction during mobilization during the first 48 hours after cardiac surgery compared to a control group.
The primary outcome:
Pain scale at patient mobilization during the first postoperative 48 hours measured by numerical pain scale.
Study design:
Prospective, randomized, doubled-blinded, single-center controlled trial with two groups:
- The ropivacaine group (42 patients): a bilateral erector spinae block will be performed after patient arrival in the intensive care unit before wake up from anesthesia with 20ml of Ropivacaine 2mg/ml bilaterally.
- The control group (42 patients): a sham block will be performed bilaterally in the same conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- * The ropivacaine group (42 patients): Echo-guided bilateral erector spinae block at the arrival in the intensive care unit. 20ml of Ropivacaine 2mg/ml for each side. * The control group (42 patients): Sham block bilaterally.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine group | Experimental | Drug: Ropivacaine 0,2% Injectable SolutionPerformance of an echo-guided bilateral erector spinae block at the arrival in the intensive care unit with 20ml of Ropivacaine 2mg/ml in each side. |
| Control group | Sham comparator | Other: Control groupPerformance of a sham block at the arrival in the intensive care unit with no drugs administration |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who undergo scheduled cardiac surgery with sternotomy for aortic or mitral valve replacement either by biological or mechanical prothesis, coronary arterial bypass surgery (CABG).
- Body Mass Index between 18,5 and 33kg/m² (extremity excluded)
- Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code
- Possession of Social Security insurance
Key exclusion criteria (16 listed)
- Emergency surgery
- Approach by thoracotomy
- Heart transplant
- Aortic dissection or chirurgical act on ascending thoracic Aorta
- Redo surgery.
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 SolutionEcho-guided bilateral erector spinae block | Drug | Ropivacaine group |
| Control groupSham block | Other | Control group |
Primary outcome
Change of pain score during cough
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough
18 secondary outcomes
Change of pain score during patient tourn in the bed (lateralization) for nursing
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Change of pain score during central venous pressure measuring
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Change of sternal pain score at rest
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Change of dorsal pain evaluation at rest
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Opioid consumption
Time frame: 48 hours after intervention
Satisfaction assessed by the Likert scale
Time frame: 48 hours after intervention
Spirometry measure of forced vital capacity (FVC)
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of forced expiratory volume in one second (FEV1)
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of FEV1/FVC
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of peak expiratory flow (PEF)
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75%
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragmatic excursion
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragm thickness
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragm thickening fraction
Time frame: Up to 6 months after surgery (end of Hospital stay)
Digestive function
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Digestive function
Time frame: Up to 6 months after surgery (end of Hospital stay)
Time of drain removal
Time frame: Up to 6 months after surgery (end of Hospital stay)
Postoperative complications
Time frame: Up to 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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.
Vedat Eljezi principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine 0,2% Injectable Solution in people with Cadiac Surgery and Median Sternotomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 6 Jul 2023. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain score during cough (time frame: From patient awakening to 48 hours later (one evalution every 4 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 6 Jul 2023.