Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively

Official Title
-----------------
Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery

Conditions
-----------------
Cardiac Surgery, Ultrasound-guided Parasternal Block, Postoperative Pulmonary Complications, Pulmonary Function Testing

Intervention / Treatment
-----------------
* Drug: parasternal block
* Drug: Standard pain management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age Elective cardiac surgery under CEC with sternotomy Written informed consent from the patient. Women of childbearing age must have a negative urine HCG pregnancy test. Exclusion Criteria: Thoracotomy approach Mini-sternotomy approach Opioid drug dependence or chronic opioid drug use Chronic benzodiazepine use (respiratory depressant treatment or treatment that may affect postoperative respiratory function) Contraindication or allergy to local anesthetics Emergency surgery Acute infective endocarditis Immunosuppressive or steroid treatment (prednisone > 0.5mg/kg/day or equivalent) AIDS with CD4 count <200/mm3 Autoimmune disorder Transplant recipient Inclusion in another study within the last 30 days. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional arm<br>the experimental arm will receive the parasternal block with injection of locoregional anesthesia | Drug: parasternal block<br>* Echo-guided loco-regional anesthesia by bilateral parasternal block in immediate preoperative. The drug used is Ropivacaine 2mg/ml, 0.2%. Injection of 20ml per side, under ultrasound control, after general anaesthesia and before skin incision, and therefore before surgery<br>|
| Active Comparator: control arm not requiring loco-regional anesthesia.<br>the control arm will receive a standard treatment, without locoregional anesthesia | Drug: Standard pain management<br>* Standard pain management care involves a multimodal strategy that includes the use of intravenous analgesics. Morphine medications are the mainstay of pain management<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative forced vital capacity (FVC) | The primary endpoint was the change (reduction) in postoperative forced vital capacity (FVC) between the preoperative measurement and at D1 postoperatively. Forced Vital Capacity measured by SPIROLAB spirometry (Appendix). Vital capacity is expressed as % of theoretical value. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of FCV between both groups | Respiratory functional investigations at day 2 is forced vital capacity (FVC) | at day 2 | 
| Variation of FCV between both groups | Respiratory functional investigations at 1 month is forced vital capacity (FVC) | at 1 month | 
| Variation of FCV between both groups | Respiratory functional investigations at 3 months is forced vital capacity (FVC) | at 3 months | 
| Variation of forced expiratory volume in 1 second (FEV1) | Respiratory functional investigations at day 2 are forced expiratory volume in 1 second (FEV1) | at day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac surgery, Ultrasound-guided Parasternal Block, Postoperative pulmonary complications, Pulmonary function testing