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

NCT ID: NCT03734159

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-13
• Study Completion Date: 2019-11-07

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.

Conditions

Coronary Bypass Graft Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

parasternal block

preoperative parasternal block by ropivacaine injection

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: 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)

physiological serum

sodium chloride injection

Group Type: PLACEBO_COMPARATOR

sodium chloride 0.9%

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien Bloc, MD

Role: PRINCIPAL_INVESTIGATOR

CMC Ambroise Paré

Locations

CMC Ambroise Paré

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

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33990437 (View on PubMed)

Other Identifiers

2018/07

Identifier Type: -

Identifier Source: org_study_id