The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery
- Conditions
- Coronary Bypass Graft Stenosis
- Interventions
- Registration Number
- NCT03734159
- Lead Sponsor
- CMC Ambroise Paré
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description parasternal block Ropivacaine preoperative parasternal block by ropivacaine injection physiological serum sodium chloride 0.9% sodium chloride injection
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method Hemodynamic response : heart rate Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup Measure of heart rate in bpm
Dose of hypnotic drug Intraoperative period : from induction of anesthesia to skin closure Total amount of propofol administered during surgery
Pain level during extubation: Numeric scale 8 hours Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)
Complications 7 days Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension
Hemodynamic response : arterial blood pressure Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup Measure of diastolic and systolic arterial blood pressure in mmHg
Hemodynamic response : patient state index Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup Measure of patient state index ranging from 0 to 100 (0=very deep anesthesia, 100=no hypnotic state)
Dose of analgesic drug Intraoperative period : from induction of anesthesia to skin closure Total amount of remifentanil administered during surgery
Inflammatory response 7 days 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)
Trial Locations
- Locations (1)
CMC Ambroise Paré
🇫🇷Neuilly-sur-Seine, Ile-de-France, France