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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Bypass Graft Stenosis
• Intervention / Treatment: Drug: Ropivacaine; Drug: sodium chloride 0.9%

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: parasternal block; preoperative parasternal block by ropivacaine injection	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)
Placebo Comparator: physiological serum; sodium chloride injection	Drug: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré
• Investigators: Principal Investigator: Sébastien Bloc, MD, CMC Ambroise Paré

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): June 21, 2019
• Study Completion (Actual): November 7, 2019

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Sternotomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2018/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No