Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Drug: Ropivacaine (in one arm); catheterization (in both).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled cardiac surgery. Exclusion Criteria: - surgery in emergency thoracotomy cardiac graft redo pregnancy patient's refusal minor or adult under legal protection psychiatric ongoing disease addiction to opiates ongoing opiate treatment inability to use a PCA device respiratory insuffiency (Vital capacity or maximal expired volume per sec. < 50% of the expected value, or mean PAP > 50 mmHg) intra-aortic balloon severe renal insuffiency history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine<br> | Drug: Ropivacaine (in one arm); catheterization (in both).<br>* Parallel study with two groups: ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump. same protocol, with normal saline instead of ropivacaine.<br>|
| Other: normal saline<br> | Drug: Ropivacaine (in one arm); catheterization (in both).<br>* Parallel study with two groups: ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump. same protocol, with normal saline instead of ropivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sternotomy, Pain, Respiratory function, Opiates, Patient-controlled, Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied