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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| parasternal block | Experimental | preoperative parasternal block by ropivacaine injection |
|
| physiological serum | Placebo Comparator | sodium chloride injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Intraoperative period : from intubation to sternal retractor setup |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic response : heart rate | Measure of heart rate in bpm | Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup |
| Hemodynamic response : arterial blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien Bloc, MD | CMC Ambroise Paré | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33990437 | Result | 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. |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 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) |
|
Measure of diastolic and systolic arterial blood pressure in mmHg
| 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) | 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 | Intraoperative period : from induction of anesthesia to skin closure |
| Dose of analgesic drug | Total amount of remifentanil administered during surgery | 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) | 7 days |
| Pain level during extubation: Numeric scale | Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain) | 8 hours |
| Complications | Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension | 7 days |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |