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

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Ropivacaine

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