CHU
Clermont-Ferrand, 63000, France
NCT Number: NCT05160298
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
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Notify Me18 year–78 year
All sexes
Interventional
Phase 2
Clermont-Ferrand, 63000, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Echo-guided bilateral erector spinae block
Sham block
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time frame: 48 hours after intervention
Total opioid consumption since the awakening of the patient during 48 postoperative hours.
Time frame: 48 hours after intervention
Subjective Assessment of pain management by the patient on a Likert scale going from 0 to 4 where 4 is excellent
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Assessment of the change of FVC by repeating spirometry during the hospital stay
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Assessment of the change of FEV1 by repeating spirometry during the hospital stay
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Assessment of the change of FEV1/FVC by repeating spirometry during the hospital stay
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Assessment of the change of PEF by repeating spirometry during the hospital stay
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Assessment of the change of FEF 25%, FEF 50%, FEF 75%, FEF 25-75% by repeating spirometry during the hospital stay
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Assessment of the diaphragmatic excursion by repeating diaphragm echography during the hospital stay
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Assessment of the diaphragmatic thickness by repeating diaphragm echography during the hospital stay
Time frame: Up to 6 months after surgery (end of Hospital stay)
Assessment of the diaphragmatic thickening fraction (%) by repeating diaphragm echography during the hospital stay
Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery
Time of recovery of normal bowel function. Beginning of oral feeding
Time frame: Up to 6 months after surgery (end of Hospital stay)
Time of recovery of normal bowel function.. Incidence of postoperative nausea and vomiting
Time frame: Up to 6 months after surgery (end of Hospital stay)
Time when the drain are removed of the patient
Time when the drain are removed of the patient
Time frame: Up to 1 month after surgery
occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications
University Hospital, Clermont-Ferrand
Other
Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery
Acronym: ESB-Sterno
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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