Intrapleural Ropivacaine Infusion in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine, 0.9 % NaCl.
- Who it may be relevant to
- Registry conditions: Cardiac Surgery, Coronary Artery Disease, Valvular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrapleural Ropivacaine Infusion in Cardiac Surgery: Randomized Double-blind Controlled Study
Overview
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
- Drug Ropivacaine
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. - Drug 0.9 % 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.
Primary outcome measures
- Quality of recovery after anesthesia (QoR15) questionnaire [Time frame: 24 hours after surgery]
Secondary outcome measures (3)
- pO2/FiO2 ratio [Time frame: 6, 12, 24 hours after surgery]
- Morphine equvalents, mg/day [Time frame: 24 hours after surgery]
- Pain assessed by Visual analog scale [Time frame: 6, 12, 24, 48 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Russia · 2 centers
- Saint-Petersburg university hospital — Saint Petersburg
- Primorskiy general hospital #1 — Vladivostok
Identifiers
NCT: NCT07116343 · SPBU IRICS study