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| Name | Class |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral Block | Active Comparator | If the patient is randomized to group Paravertebral Block, the anesthesiologist performs TPVB after induction of general anesthesia. The patient is positioned in lateral decubitus 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. |
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| Erector Spinae Plane Block | Experimental | If the patient is randomized to group "Erector Spinae Plane Block", the anesthesiologist performs the ESPb block after 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side | Procedure | Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side |
| 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 measurement) | 6 hours from the end of the surgery |
| 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)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier MONTANDRAU, MD | Institut Mutualiste Montsouris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Mutualiste montsouris | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41290467 | Derived | Montandrau O, Kattou F, Arana H, Rekik M, Ait Hamou N, Weisslinger SJ, Teil E, Mekaouar S, Bargaoui A, Bouattour K, Bey Boumezrag C, Lacombe JM, Lebatard N, Zannis K, Beaussier M. Ultrasound-guided thoracic paravertebral block versus erector spinae plane block analgesia for cardiac surgery with median sternotomy: a noninferiority randomised controlled trial. Br J Anaesth. 2026 Feb;136(2):687-694. doi: 10.1016/j.bja.2025.10.039. Epub 2025 Nov 24. |
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| Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side | Procedure | Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side |
|
| 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 measurement) | 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 |
| Complication(s) associated to the procedure | Pneumothorax, major hematoma, sympathetic block | 48 hours from the end of the surgery |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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