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This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.
Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine | Experimental |
| |
| normal saline | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine (in one arm); catheterization (in both). | Drug | Parallel study with two groups:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale. | every 4 hours during 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption on PCA device | every 4 hours during 48 hours | |
| Pain score at rest, expressed on a visual analogue scale. | every 4 hours during 48 hours | |
| Vital capacity and inspiratory reserve volume, related to the preoperative values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vedat Eldjezi, MB | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22266899 | Result | Eljezi V, Duale C, Azarnoush K, Skrzypczak Y, Sautou V, Pereira B, Tsokanis I, Schoeffler P. The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):166-74. doi: 10.1097/AAP.0b013e318240957f. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| daily during 48 hours |
| Postoperative blood level of troponin | every 8 hours during 48 hours |
| Arterial blood gases | every 4 hours during 48 hours |
| Time to first flatus | daily during 48 hours |
| Number of participants with adverse events | nausea and vomiting, pruritus | daily during 48 hours |
| Postoperative blood level of ropivacaine at day + 1 and day + 2 | daily during 48 hours |
| Signs of intoxication to ropivacaine | eventual reports |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D000588 |
| Amines |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |