Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters

Study Overview
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Brief Summary
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Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of coughing, deep breathing, and early mobilisation. It may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.

Detailed Description
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Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.

Official Title
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Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters.

Conditions
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Scheduled Cardiac Surgery, Sternotomy, Elderly Patients, Obesity, Chronic Bronchitis

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled cardiac surgery (aortic or mitral valve replacement, or coronary bypass surgery) with sternotomy. Patients will be at risk of noncardiac postoperative complications, i.e. age over 75, BMI over 30, pulmonary disease, or active smoking habit Exclusion Criteria: surgery in emergency thoracotomy cardiac graft redo aortic dissection age over 85 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 insufficiency (Vital capacity or maximal expired volume per sec. < 50% of the expected value, or mean PAP > 50 mmHg) cardiac failure or EF < 40% or intra-aortic balloon use pulmonary hypertension over 50 mmHg severe renal insufficiency history of allergy or intolerance to: morphine, acetaminophen, ropivacaine.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaïne<br>Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine. | Drug: Ropivacaine<br> <br> |
| Placebo Comparator: Placebo<br>Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The deadline for obtaining all criteria consistent with an output of postoperative intensive care | The criteria will be considered by an independent adjudication committee unaware of the treatment given, according to a predefined checklist, whatever the actual delay for discharge. The checklist was built with the help of published recommendations [Camp et al. J Card Surg 2009; 24:414]. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery time |  | 24 hours | 
| Quantity of sufentanil administered |  | 72 hours | 
| Total morphine consumption |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sternotomy, Anesthesia, Post-operative pain