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

Coronary Bypass Graft Stenosis Clinical Trial

— PARA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734159
• Other study ID #: 2018/07
• Status: Completed
• Phase: Phase 4
• Start date: December 13, 2018
• Est. completion date: November 7, 2019

Study information

• Verified date: December 2018
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 7, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Bypass Graft Stenosis

Intervention

Drug:
• Ropivacaine
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)
• sodium chloride 0.9%
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)

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Dose of hypnotic drug	Total amount of propofol administered during surgery	Intraoperative period : from induction of anesthesia to skin closure
Secondary	Dose of analgesic drug	Total amount of remifentanil administered during surgery	Intraoperative period : from induction of anesthesia to skin closure
Secondary	Inflammatory response	Serum concentrations of cytokines in pg/ml (composite : pro- (IL-6, IL-8, IL-1ß, TNF-a, IFN-?) and anti-inflammatory (IL-10) cytokines)	7 days
Secondary	Pain level during extubation: Numeric scale	Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)	8 hours
Secondary	Complications	Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension	7 days