Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery

Study Overview
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Brief Summary
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The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy

Detailed Description
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Background: Pain after cardiac surgery is mostly localized at the sternotomy site. To improve postoperative pain management a number of technics involving loco-regional anesthesia have been developed. The epidural analgesia is the gold standard but the risk of epidural hematoma with heparinization in this surgery avoids its utilization in clinical practice. The paravertebral block can be used equally but there is a risk of pneumothorax. The erector spinae plane block could be a solution as it is a more superficial block. It's efficacity was proven in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. A bilateral erector spinae plane block after cardiac surgery could significantly reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The main objective of this to study is to examine the efficacity of a single-shot bilateral erector spinae plane block on pain reduction during mobilization during the first 48 hours after cardiac surgery compared to a control group. The primary outcome: Pain scale at patient mobilization during the first postoperative 48 hours measured by numerical pain scale. Study design: Prospective, randomized, doubled-blinded, single-center controlled trial with two groups: The ropivacaine group (42 patients): a bilateral erector spinae block will be performed after patient arrival in the intensive care unit before wake up from anesthesia with 20ml of Ropivacaine 2mg/ml bilaterally. The control group (42 patients): a sham block will be performed bilaterally in the same conditions.

Official Title
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Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery

Conditions
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Cadiac Surgery, Median Sternotomy, Regional Anesthesia, Postoperative Pain

Intervention / Treatment
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* Drug: Ropivacaine 0,2% Injectable Solution
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo scheduled cardiac surgery with sternotomy for aortic or mitral valve replacement either by biological or mechanical prothesis, coronary arterial bypass surgery (CABG). Body Mass Index between 18,5 and 33kg/m² (extremity excluded) 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 or chirurgical act on ascending thoracic Aorta Redo surgery. Pregnant women Protected minors or adults Pre-existing psychiatric pathology including known states of opioid addiction Long-term opioid medication (>1month) 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 allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates). Known allergy or hypersensitivity to any of excipients of the study drugs or analgesia protocol Refusal of the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 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
Interventional Model Description: The ropivacaine group (42 patients): Echo-guided bilateral erector spinae block at the arrival in the intensive care unit. 20ml of Ropivacaine 2mg/ml for each side. The control group (42 patients): Sham block bilaterally.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine group<br>Performance of an echo-guided bilateral erector spinae block at the arrival in the intensive care unit with 20ml of Ropivacaine 2mg/ml in each side. | Drug: Ropivacaine 0,2% Injectable Solution<br>* Echo-guided bilateral erector spinae block<br>|
| Sham Comparator: Control group<br>Performance of a sham block at the arrival in the intensive care unit with no drugs administration | Other: Control group<br>* Sham block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain score during cough | Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough | From patient awakening to 48 hours later (one evalution every 4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain score during patient tourn in the bed (lateralization) for nursing | Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization | From patient awakening to 48 hours later (one evalution every 4 hours) | 
| Change of pain score during central venous pressure measuring | Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization | From patient awakening to 48 hours later (one evalution every 4 hours) | 
| Change of sternal pain score at rest | Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization | From patient awakening to 48 hours later (one evalution every 4 hours) | 
| Change of dorsal pain evaluation at rest | Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization | From patient awakening to 48 hours later (one evalution every 4 hours) | 
| Opioid consumption | Total opioid consumption since the awakening of the patient during 48 postoperative hours. | 48 hours after intervention | 
| Satisfaction assessed by the Likert scale | Subjective Assessment of pain management by the patient on a Likert scale going from 0 to 4 where 4 is excellent | 48 hours after intervention | 
| Spirometry measure of forced vital capacity (FVC) | Assessment of the change of FVC by repeating spirometry during the hospital stay | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Spirometry measure of forced expiratory volume in one second (FEV1) | Assessment of the change of FEV1 by repeating spirometry during the hospital stay | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Spirometry measure of FEV1/FVC | Assessment of the change of FEV1/FVC by repeating spirometry during the hospital stay | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Spirometry measure of peak expiratory flow (PEF) | Assessment of the change of PEF by repeating spirometry during the hospital stay | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75% | Assessment of the change of FEF 25%, FEF 50%, FEF 75%, FEF 25-75% by repeating spirometry during the hospital stay | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Diaphragmatic excursion | Assessment of the diaphragmatic excursion by repeating diaphragm echography during the hospital stay | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Diaphragm thickness | Assessment of the diaphragmatic thickness by repeating diaphragm echography during the hospital stay | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Diaphragm thickening fraction | Assessment of the diaphragmatic thickening fraction (%) by repeating diaphragm echography during the hospital stay | Up to 6 months after surgery (end of Hospital stay) | 
| Digestive function | Time of recovery of normal bowel function. Beginning of oral feeding | The day before surgery, the first or second day after surgery and the seventh day after surgery | 
| Digestive function | Time of recovery of normal bowel function.. Incidence of postoperative nausea and vomiting | Up to 6 months after surgery (end of Hospital stay) | 
| Time of drain removal | Time when the drain are removed of the patient Time when the drain are removed of the patient | Up to 6 months after surgery (end of Hospital stay) | 
| Postoperative complications | occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications | Up to 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative analgesia, Erector spinae plane block, Local anesthetics, Ropivacaine, Sternotomy