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The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.
Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint (pain at rest, pain during patient mobilization and opioid consumption).
Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits from the placement of two multihole catheters in BLS position:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine group | Experimental | Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation | The technique is considered as a fail if : pain rest > 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization > 3.5/10 (0 = no pain; 10 maximum pain) | Day 2 postoperatively. |
| Opioid consumption | The technique is considered as a fail if morphine consumption > 35 mg | Day 2 postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | Days of ICU and hospital stay | Up to 6 months |
| Hospital length of stay | Days of ICU and hospital stay | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vedat Eljezi, Dr | Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire | Clermont-Ferrand | Puy De Dôme | 63000 | France |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
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| Patient satisfaction | Patient satisfaction evaluation from the patient based on a simple Likert scale: 0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent. | Day 2 postoperatively. |
| Postoperative nausea and vomiting | assessed by the Wengritzky intensity scale (if total score > 50, the nausea and vomiting are clincally significant) | Day 1 and 2 postoperatively. |
| Respiratory complications | Occurrence of postoperative respiratory complications | Up to 6 months |
| Cardiac complications | Occurrence of postoperative cardiac complications | Up to 6 months |
| Neurological complications | Occurrence of postoperative neurological complications | Up to 6 months |
| Renal,complications | Occurrence of postoperative renal complications | Up to 6 months |
| Infectious complications | Occurrence of postoperative infectious complications | Up to 6 months |
| Chronic pain evaluation | Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score | Assessed at the 6th postoperative month |
| D000588 |
| Amines |