Cardiac Surgery, Coronary Artery Disease, Valvular Diseases
Conditions
Keywords
cardiac surgery, quality of recovery, ropivacaine, postoperative analgesia
Brief summary
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.
Interventions
DRUGRopivacaine
The 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.
DRUG0.9 % NaCl
The 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.
Sponsors
Saint Petersburg State University, Russia
Primorsky Regional Clinical Hospital No. 1
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Contraindications for ropivacaine * Redo surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery after anesthesia (QoR15) questionnaire | 24 hours after surgery | ranged from 0 to 150 points, where 0 is the worst and 150 is the best. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pO2/FiO2 ratio | 6, 12, 24 hours after surgery | — |
| Morphine equvalents, mg/day | 24 hours after surgery | — |
| Pain assessed by Visual analog scale | 6, 12, 24, 48 hours | from 0 to 10 when 0 is worst and 10 is best |
Countries
Russia
Contacts
CONTACTSergey M Efremov, MD, PhD
Outcome results
None listed