Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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: The ropivacaine group (40 patients): 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. The control group (80 patients) from the two previous studies who underwent standard analgesia with PCA morphine.

Official Title
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The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

Conditions
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Scheduled Cardiac Surgery, Age Under 85 Years

Intervention / Treatment
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* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery Age under 85 years Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code Possession of Social Security insurance. Exclusion Criteria: Emergency surgery Approach by thoracotomy Heart transplant Aortic dissection Redo surgery. Pregnant women Refusal of the protocol Protected minors or adults Pre-existing psychiatric pathology including known states of opioid addiction Long-term opioid medication Physical or intellectual inability to use a PCA Severe heart failure (ejection fraction less than 40% or PAH > 50 mmHg) Preoperative cardiogenic shock Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula Known hypersensitivity to local anesthetics or to any component of the catheter Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine group<br>Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively. | Drug: Ropivacaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative analgesia, Sternotomy, Local anesthetics