The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Bypass Graft Stenosis

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: sodium chloride 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parasternal block<br>preoperative parasternal block by ropivacaine injection | Drug: Ropivacaine<br>* 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)<br>|
| Placebo Comparator: physiological serum<br>sodium chloride injection | Drug: sodium chloride 0.9%<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional Anesthesia, Sternotomy