Clinical Trials Directory

Trials / Completed

CompletedNCT03734159

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
35 (actual)
Sponsor
CMC Ambroise Paré · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGRopivacaineInjection 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)
DRUGsodium 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)

Timeline

Start date
2018-12-13
Primary completion
2019-06-21
Completion
2019-11-07
First posted
2018-11-07
Last updated
2026-04-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03734159. Inclusion in this directory is not an endorsement.