coronary artery bypass graft MedDRA version: 20.0 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865
Conditions
Interventions
Trade Name: ROPIVACAINE KABI 7,5 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ropivacaine
CAS Number: 84057-95-4
Other descriptive name: ROPIVACAINE HYDROCHLORIDE
Concentrati
Sponsors
CMC Ambroise Paré
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 Years and older - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Show that the preoperative realization of a parasternal block reduces the posology of remifentanil administered during sternotomies;Secondary Objective: Evaluate the effect of parasternal block on : 1. Hemodynamic response 2. Dose of hypnotic (propofol) and analgesic (remifentanil) drugs during surgery 3. Inflammatory response 4. Pain level during extubation 5. Complications;Primary end point(s): Maximal dose of remifentanil required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during intubation, skin incision, sternotomy and sternal retractor setup;Timepoint(s) of evaluation of this end point: Intraoperative period : from intubation to sternal retractor setup | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Measure of hemodynamic parameters (arterial blood pressure and heart rate) and patient state index (PSi) 2. Dose of propofol and remifentanil administered during surgery 3. Serum concentrations of cytokines 4. Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain), during extubation 5. Complication rate : - Complications related to parasternal block (wrong distribution of the local anesthetic, infection at injection site, rhythm disorders caused by intravascular injection of the local anesthetic) - Post-operative complications (acute respiratory distress syndrome, pneumopathy, kidney failure, hypertension);Timepoint(s) of evaluation of this end point: 1. Intraoperative period : from the start of general anesthesia maintenance, i.e. PSi within the 25-50 range, to the fifth minute after sternal retractor setup (refers to criteria 1) 2. Intraoperative period : from induction of anesthesia to skin closure (refers to criteria 2) 3. At induction of anesthesia, at the arrival in intensive care, at day 1, day 2, day 3, day 5 and day 7 at the time of the morning blood collection (refers to criteria 3) 4. During extubation (refers to criteria 4) 5. 7 days after surgery (refers to criteria 5) | — |
Countries
France
Contacts
Public ContactEquipe Recherche Clinique
CMC Ambroise Paré
Outcome results
None listed