Clinical trial NCT03734159: The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Bypass Graft Stenosis
Keywords: Regional Anesthesia
Sternotomy
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Intraoperative period : from intubation to sternal retractor setup
Secondary outcomes:
measure: Hemodynamic response : heart rate
timeFrame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
measure: Hemodynamic response : arterial blood pressure
timeFrame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
measure: Hemodynamic response : patient state index
timeFrame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
measure: Dose of hypnotic drug
timeFrame: Intraoperative period : from induction of anesthesia to skin closure
measure: Dose of analgesic drug
timeFrame: Intraoperative period : from induction of anesthesia to skin closure
measure: Inflammatory response
timeFrame: 7 days
measure: Pain level during extubation: Numeric scale
timeFrame: 8 hours
measure: Complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
state: Ile-de-France
Study officials:
affiliation: CMC Ambroise Paré
name: Sébastien Bloc, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.