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

NCT03734159 | Completed Phase 4

• 1 other identifier: 2018/07
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Bypass Graft Stenosis

Keywords

Regional Anesthesia; Sternotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Hemodynamic response : heart rate

  Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup

• Hemodynamic response : arterial blood pressure

  Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup

• Hemodynamic response : patient state index

  Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup

• Dose of hypnotic drug

  Intraoperative period : from induction of anesthesia to skin closure

• Dose of analgesic drug

  Intraoperative period : from induction of anesthesia to skin closure

Study Arms (2)

parasternal block

EXPERIMENTAL

preoperative parasternal block by ropivacaine injection

Drug: Ropivacaine

physiological serum

PLACEBO COMPARATOR

sodium chloride injection

Drug: sodium chloride 0.9%

Interventions

Ropivacaine DRUG

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)

parasternal block

sodium chloride 0.9% DRUG

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)

physiological serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Related Publications (1)

• 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.

  PMID: 33990437 RESULT

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sébastien Bloc, MD

  CMC Ambroise Paré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: December 13, 2018
• Primary Completion: June 21, 2019
• Study Completion: November 7, 2019
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)