About this trial
For many patients, a primary source of postoperative pain following cardiac surgery is the presence of pleural drains, which the surgeon places at the end of the operation and maintains for 1 to 3 days. One promising method of pain management after cardiac surgery is interpleural analgesia, particularly when traditional analgesic methods, such as systemic opioids or epidural anesthesia, may be limited due to the risk of complications. Interpleural analgesia involves the introduction of local anesthetics directly into the pleural cavity through drainage tubes placed after cardiac surgery. This method targets pain receptors in the chest area, providing effective analgesia without significant systemic effects. Several clinical studies have confirmed the safety and efficacy of intrapleural administration of anesthetics after thoracic surgery. The aim of this randomised double-blind placebo controlled study is to test the hypothesis that, in patients after cardiac surgery, the quality of recovery from anesthesia with intrapleural use of ropivacaine is superior to that with a placebo.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled cardiac surgery using a standard median sternotomy.
Planned opening of the pleural cavities.
Age more than 18 years.
Signed informed consent to participate in the study.
Disqualifiers
Contraindications for ropivacaine
Redo surgery
Trial design
Parallel
Treatments tested in this trial
Ropivacaine
DrugThe patient will receive 0.2% ropivacaine (20.0 ml) into the pleural cavity intraoperatively before sternal closure. A continuous infusion of 0.2% ropivacaine will be administered through a microcatheter into the drained pleural cavity, with titration of the infusion rate. The initial infusion rate is set at 10 ml/hour.
0.9 % NaCl
DrugThe patient will receive 20.0 ml of a 0.9% sodium chloride solution into the pleural cavity intraoperatively, prior to sternal closure. A continuous infusion of 0.9% sodium chloride solution will then be administered through a microcatheter into the drained pleural cavity. The initial infusion rate is set at 10 ml/hour.
Treatment groups
Trial outcomes
Primary outcomes
Quality of recovery after anesthesia (QoR15) questionnaire
ranged from 0 to 150 points, where 0 is the worst and 150 is the best.
Secondary outcomes
pO2/FiO2 ratio
Morphine equvalents, mg/day
Pain assessed by Visual analog scale
from 0 to 10 when 0 is worst and 10 is best
Other outcomes
Postoperative complications
Composite (myocardial infarction, stroke, delirium, new onset atrial fibrillation, infections)
Hospital mortality
Death during hospitalisation
Length of hospitalisation
Number of days in hospital during initial hospitalisation
Sternal wound dehiscence
Sponsors and contacts
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Saint Petersburg State University, Russia
Lead sponsor
Primorsky Regional Clinical Hospital No. 1
Collaborator