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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine group | Experimental | 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. |
|
| Control group | Sham Comparator | Performance of a sham block at the arrival in the intensive care unit with no drugs administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0,2% Injectable Solution | Drug | Echo-guided bilateral erector spinae block |
| |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vedat Eljezi | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Clermont-Ferrand | 63000 | France |
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The patient will be under sedation during the block performance. Th nurse in charge to the patient will be absent during the block performance and the block will be realized by the practitioner who will not take care of the patient during his hospitalization
| Control group |
| Other |
Sham block |
|
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 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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