Coronary Bypass Graft StenosisPhase 4PARANCT03734159
The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery
A Phase 4 study testing Ropivacaine and sodium chloride 0.9% in people with Coronary Bypass Graft Stenosis, run by CMC Ambroise Paré at 1 site in France.
Trial summary
Patients undergoing coronary artery bypass grafting are at risk for perioperative myocardial ischemia. Episodes of tachycardia and hypertension, which are associated with an increase in myocardial oxygen consumption, are predictive events of these ischemia. During cardiac surgery by sternotomy, some maneuvers, e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bypass Graft Stenosis
- What is being tested?
- Ropivacaine and sodium chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2018to 7 Nov 2019
- Phase
- Phase 4
- 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
- Patients undergoing coronary artery bypass graft requiring sternotomy other than re-interventions and combined surgeries
- Consent for participation
- Affiliation to the french social security system
Who cannot join
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curator or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
- Neuropathic disease
- Constitutional coagulation disorders
- Kidney insufficiency
Show all 14Show fewer
- Sensitivity to nonsteroidal anti-inflammatory drugs
- Hypersensitivity to local anaesthetics
- Chronic use of opioid analgesics
- Corticosteroid treatment or immunosuppressive therapy
- Autoimmune disease
- Chronic pain syndrome or fibromyalgia
- Emergency cardiac surgery
- Hypovolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Parasternal Block to Limit the Doses of Anesthetics Necessary for the Maintenance of Arterial Blood Pressure and Heart Rate in the Recommended Values During Sternotomy in Patients Undergoing Coronary Artery Bypass Graft
Patients undergoing coronary artery bypass grafting are at risk for perioperative myocardial ischemia. Episodes of tachycardia and hypertension, which are associated with an increase in myocardial oxygen consumption, are predictive events of these ischemia.
During cardiac surgery by sternotomy, some maneuvers, e.g. intubation, skin incision, sternotomy and cannulation, may be associated with tachycardia and/or increases in blood pressure despite an adequate level of anesthesia. Usually these episodes are controlled by the administration of a high-dose of anesthetic agents.
Read more
The parasternal block, by bolus or continuous infusion through a single catheter, showed its effectiveness on postoperative pain after sternotomy. It allows a blocking of anterior branches of intercostal nerves at the lateral edge of the sternum; branches in charge of innervation of the sternum and the overlying skin surface.
The preoperative parasternal block, once general anesthesia performed, could provide an effective level of locoregional anesthesia of the chest wall, thus limiting the occurrence of episodes of tachycardia and / or hypertension without having to resort to massive doses of anesthetic agents during sternotomy in patients undergoing coronary bypass surgery.
Read the detailed description
This randomized double blinded placebo-controlled clinical trial will include patients undergoing coronary artery bypass grafting.
Locoregional anesthesia of the chest wall will be performed under ultrasound, once general anesthesia performed. A total volume of 60 ml of sodium chloride 0.9% (placebo group) or ropivacaine 0.25% (experimental group) divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5) will be injected.
- Conditions
- Coronary Bypass Graft Stenosis
- Being tested
- Ropivacaine, sodium chloride 0.9%
- Keywords
- Regional Anesthesia, Sternotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Injection of 60 ml of ropivacaine 0.25% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)
sodium chloride 0.9%Drug
Injection of 60 ml of sodium chloride 0.9% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)
| Study group | Role | What they receive |
|---|---|---|
| parasternal block | Experimental | preoperative parasternal block by ropivacaine injection Receives: Drug: Ropivacaine |
| physiological serum | Placebo comparator | sodium chloride injection Receives: Drug: sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Show that the preoperative realization of a parasternal block limites the posology of remifentanil administered during sternotomies to maintain blood pressure and heart rate within recommended ranges
Maximal dose of remifentanil (morphine peak) required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during intubation, skin incision, sternotomy and sternal retractor setup
Measured: Intraoperative period : from intubation to sternal retractor setup
Secondary outcomes (8)
Hemodynamic response : heart rate
Measure of heart rate in bpm
Measured: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
Hemodynamic response : arterial blood pressure
Measure of diastolic and systolic arterial blood pressure in mmHg
Measured: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
Hemodynamic response : patient state index
Measure of patient state index ranging from 0 to 100 (0=very deep anesthesia, 100=no hypnotic state)
Measured: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
Dose of hypnotic drug
Total amount of propofol administered during surgery
Measured: Intraoperative period : from induction of anesthesia to skin closure
Dose of analgesic drug
Total amount of remifentanil administered during surgery
Measured: Intraoperative period : from induction of anesthesia to skin closure
Inflammatory response
Serum concentrations of cytokines in pg/ml (composite : pro- (IL-6, IL-8, IL-1β, TNF-α, IFN-γ) and anti-inflammatory (IL-10) cytokines)
Measured: 7 days
Pain level during extubation: Numeric scale
Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)
Measured: 8 hours
Complications
Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start13 Dec 2018
- Primary completion21 Jun 2019
- Study completion7 Nov 2019
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 Coronary Bypass Graft StenosisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Bloc, MD, Principal investigator, CMC Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734159
- Sponsor's protocol ID
- 2018/07
- Acronym
- PARA
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquiere C, Luka M, Waldmann T, Vistarini N, Aubert S, Menager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14.
PubMed 33990437
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Parasternal Block to Limit the Doses of Anesthetics Necessary for the Maintenance of Arterial Blood Pressure and Heart Rate in the Recommended Values During Sternotomy in Patients Undergoing Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT03734159
- Acronym / sponsor ID
- PARA / 2018/07
- Conditions
- Coronary Bypass Graft Stenosis
- Keywords
- Regional Anesthesia, Sternotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 7 Nov 2018 (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.
Patients undergoing coronary artery bypass grafting are at risk for perioperative myocardial ischemia. Episodes of tachycardia and hypertension, which are associated with an increase in myocardial oxygen consumption, are predictive events of these ischemia.
During cardiac surgery by sternotomy, some maneuvers, e.g. intubation, skin incision, sternotomy and cannulation, may be associated with tachycardia and/or increases in blood pressure despite an adequate level of anesthesia. Usually these episodes are controlled by the administration of a high-dose of anesthetic agents.
The parasternal block, by bolus or continuous infusion through a single catheter, showed its effectiveness on postoperative pain after sternotomy. It allows a blocking of anterior branches of intercostal nerves at the lateral edge of the sternum; branches in charge of innervation of the sternum and the overlying skin surface.
The preoperative parasternal block, once general anesthesia performed, could provide an effective level of locoregional anesthesia of the chest wall, thus limiting the occurrence of episodes of tachycardia and / or hypertension without having to resort to massive doses of anesthetic agents during sternotomy in patients undergoing coronary bypass surgery.
Detailed description
This randomized double blinded placebo-controlled clinical trial will include patients undergoing coronary artery bypass grafting.
Locoregional anesthesia of the chest wall will be performed under ultrasound, once general anesthesia performed. A total volume of 60 ml of sodium chloride 0.9% (placebo group) or ropivacaine 0.25% (experimental group) divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5) will be injected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parasternal block | Experimental | Drug: Ropivacainepreoperative parasternal block by ropivacaine injection |
| physiological serum | Placebo comparator | Drug: sodium chloride 0.9%sodium chloride injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing coronary artery bypass graft requiring sternotomy other than re-interventions and combined surgeries
- Consent for participation
- Affiliation to the french social security system
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curator or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
- Neuropathic disease
- Constitutional coagulation 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 |
|---|---|---|
| RopivacaineInjection of 60 ml of ropivacaine 0.25% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5) | Drug | parasternal block |
| sodium chloride 0.9%Injection of 60 ml of sodium chloride 0.9% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5) | Drug | physiological serum |
Primary outcome
Show that the preoperative realization of a parasternal block limites the posology of remifentanil administered during sternotomies to maintain blood pressure and heart rate within recommended ranges
Time frame: Intraoperative period : from intubation to sternal retractor setup
Maximal dose of remifentanil (morphine peak) required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during intubation, skin incision, sternotomy and sternal retractor setup
8 secondary outcomes
Hemodynamic response : heart rate
Time frame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
Hemodynamic response : arterial blood pressure
Time frame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
Hemodynamic response : patient state index
Time frame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
Dose of hypnotic drug
Time frame: Intraoperative period : from induction of anesthesia to skin closure
Dose of analgesic drug
Time frame: Intraoperative period : from induction of anesthesia to skin closure
Inflammatory response
Time frame: 7 days
Pain level during extubation: Numeric scale
Time frame: 8 hours
Complications
Time frame: 7 days
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 8 Apr 2026.
- Results publication: PubMed 33990437Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquiere C, Luka M, Waldmann T, Vistarini N, Aubert S, Menager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14.
- Individual participant dataSharing planned: No
Related trials for Coronary Bypass Graft Stenosis
Recruiting
Effect of High-Intensity Interval Training Versus Home-Based Rehabilitation Program On Patients Underwent Coronary Artery Bypass Graft Surgery
Coronary Artery Disease, Coronary Graft Stenosis
Recruiting
Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease
Coronary Artery Stenosis
Recruiting
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Coronary Artery Disease, Aortic Valve Stenosis
RecruitingObservational study
Coronary CT Angio Evaluating Graft Patency in ACS Patients Treated With DAPT or Single ASA After CABG (CoCAP)
Acute Coronary Syndrome, Coronary Bypass Stenosis
Not yet recruitingObservational study
Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
Coronary Bypass Graft Stenosis, Valvular Heart Disease
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.
Sébastien Bloc, MD principal investigator
CMC Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and sodium chloride 0.9% in people with Coronary Bypass Graft Stenosis, run by CMC Ambroise Paré 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 3 inclusion and 14 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 8 Apr 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Show that the preoperative realization of a parasternal block limites the posology of remifentanil administered during sternotomies to maintain blood pressure and heart rate within recommended ranges (time frame: Intraoperative period : from intubation to sternal retractor setup). 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 NCT03734159, 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 8 Apr 2026.