Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS)

Study Overview
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Brief Summary
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The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.

Detailed Description
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Cardiac surgery causes moderate to severe postoperative pain during the first 24 - 48 post-operative hours. This pain is greatly increased by mobilization (respiratory physiotherapy) and leads to the consumption of morphine. Appropriate analgesia, along with a reduction in morphine consumption are important factors in reducing morbidity after cardiac surgery and allow better postoperative rehabilitation. Recently, the concept of multimodal analgesia has become established, which corresponds to ensuring optimal analgesia through the use of non-morphine drugs associated with locoregional analgesia. During cardiac surgery, Paravertebral block (TPVB) technique is the first line of reference in our establishment. Lately, a new approach of blocking the intercostal nerves called Erector Spinae Plane block (ESP) has been discovered. It is a technique that seems simpler and safer than TPVB. Until now, the analgesic efficacy of the ESP block compared to TPVB after cardiac surgery by sternotomy has never been studied.

Official Title
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Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.

Conditions
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Pain Syndrome, Analgesia, Anesthesia, Local

Intervention / Treatment
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* Procedure: Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of ropivacapine 3,75 mg/ml/side
* Procedure: Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing any (scheduled) surgery of the heart (valve or coronary surgery) via a median sternotomy Physical status classification (ASA) ≤3 Patients benefiting from a Social Security scheme or benefiting from it through a third party Exclusion Criteria: Emergency cardiac surgery Exclusion criteria related to cardiac surgery with thoracotomy, occurrence of aortic dissection, redo surgery. Aortic counterpulsation Preoperative cardiogenic shock LVEF< 30% Severe preoperative chronic or acute renal failure with creatinine clearance less than 30 mL / min according to the MDRD formula Pre-existing psychiatric pathology, including addiction to opioids Physical or intellectual incapacity to use a PCA Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opioids) Contraindication for performing the paravertebral block and Erector of the spine (ESP): Infection at the site of injection, severe hemostasis disorder, thoracic spinal pathology making the procedure difficult or dangerous to operate Obese patient (BMI> 30kg / m2) with poorly perceived thoracic spinous processes. vulnerable patients(Pregnant or breastfeeding women, persons benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, adults under legal protection).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral Block<br>If the patient is randomized to group Paravertebral Block, the anesthesiologist performs TPVB before induction of general anesthesia. The patient is positioned in lateral décubitus position. The anesthetist performs the bilateral paravertebral block with ultrasound identification of the paravertebral space at the T4-T5 level. Slow injection of 0.3 to 0.35 ml / kg of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of NaCl 0.9%) after aspiration test. | Procedure: Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of ropivacapine 3,75 mg/ml/side<br>* Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side<br>|
| Experimental: Erector Spinae Plane Block<br>If the patient is randomized to group Erector Spinae Plane Block, the anesthesiologist performs the ESPb block before induction of general anesthesia. The patient is positioned in a right lateral decubitus position. The anesthesiologist performs the erector block of the spine ESP with ultrasound identification at the T4-T5 level (identify the 1st rib on ultrasound then the space T4 to T5). Slow injection of 20 ml of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of 0.9% NaCl) after aspiration test. The patient is then turned in left lateral decubitus position and the contralateral block is performed according to the same procedure. | Procedure: Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side<br>* Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Pain assessment measured with Visual Analogue Scale (VAS) between 0 (no pain, best outcome) and 10 (worst possible pain, worst outcome) at mobility, (respiratory effort during peak flow meter measurment) | 6 hours from the end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the block (a) | Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm) | During the surgery | 
| Efficacy of the block (b) | Based on variations in the ANI (Anti Nociceptive Index) value (scale from 0 (maximum of nociception) to 100 (complete analgesia)) | During the surgery | 
| Efficacy of the block (c) | Based on hemodynamic response to incision and sternotomy (increase in blood pressure, measured in mmHg). Blood pressure numbers of less than 120/80 mm Hg are considered within the normal range. | During the surgery | 
| Intraoperative sufentanil consumption | Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml. | During the surgery | 
| Postoperative pain assessment | Pain assessment measured with Visual Analogue Scale between 0 (no pain, best outcome) and 10 (worst possible pain and and worst outcome) at mobility, (respiratory effort during peak flow meter measurment) | 3, 6, 12, 24, 48 hours from the end of the surgery | 
| Postoperative Morphine consumption | Morphine PCA consumption, measured in mg/h. | 3, 6, 12, 24, 48 hours from the end of the surgery | 
| Side effects associated to morphine | Incidence of post operative nausea, vomiting and sedation | 3, 6, 12, 24, 48 hours from the end of the surgery | 
| Spirometry parameters. | Spirometry measures two key factors: expiratory forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). We will look at these as a combined number known as the FEV1/FVC ratio.The higher the percentage derived from your FEV1/FVC ratio, in the absence of restrictive lung disease that causes a normal or elevated FEV1/FVC ratio, the healthier your lungs are. A low ratio suggests that something is blocking your airways | 24 hours from the end of the surgery | 
| Complication(s) associated to the procedure | Pneumothorax, major hematoma, sympathetic block | 48 hours from the end of the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Regional analgesia, Pain control