Clinical trial

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

Name
ESB-Sterno (RBHP2021ELJEZI)
Description
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
Trial arms
Trial start
2021-10-20
Estimated PCD
2022-11-20
Trial end
2022-12-20
Status
Completed
Phase
Early phase I
Treatment
Ropivacaine 0,2% Injectable Solution
Echo-guided bilateral erector spinae block
Arms:
Ropivacaine group
Control group
Sham block
Arms:
Control group
Size
84
Primary endpoint
Change of pain score during cough
From patient awakening to 48 hours later (one evalution every 4 hours)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* 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.\n* The control group (42 patients): Sham block bilaterally.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}
Updated at
2023-07-06

1 organization

1 product

4 indications

Indication
Cardiac Surgery