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| Name | Class |
|---|---|
| Primorsky Regional Clinical Hospital No. 1 | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrapleural ropivacaine | Experimental |
| |
| Intrapleural placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery after anesthesia (QoR15) questionnaire | ranged from 0 to 150 points, where 0 is the worst and 150 is the best. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| pO2/FiO2 ratio | 6, 12, 24 hours after surgery | |
| Morphine equvalents, mg/day | 24 hours after surgery | |
| Pain assessed by Visual analog scale |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Composite (myocardial infarction, stroke, delirium, new onset atrial fibrillation, infections) | at discharge (assessed up to 30 days) |
| Hospital mortality | Death during hospitalisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey M Efremov, MD, PhD | Contact | 79137946090 | efremovsergm@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Petersburg university hospital | Recruiting | Saint Petersburg | Russia |
IPD will be available by the reasonable request
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| 0.9 % NaCl | Drug | 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. |
|
from 0 to 10 when 0 is worst and 10 is best |
| 6, 12, 24, 48 hours |
| At discharge (assessed up to 6 months) |
| Length of hospitalisation | Number of days in hospital during initial hospitalisation | At discharge (assessed up to 6 months) |
| Sternal wound dehiscence | At discharge (assessed up to 6 months) |
| Primorskiy general hospital #1 | Recruiting | Vladivostok | Russia |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |