Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

• Status: Recruiting
• Trial end date: 2022-04-22
• Target enrollment: 0
• Participant gender: All

Summary

The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.

• 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: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery

• Age under 85 years

• 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

• Redo surgery.

• Pregnant women

• Refusal of the protocol

• Protected minors or adults

• Pre-existing psychiatric pathology including known states of opioid addiction

• Long-term opioid medication

• 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 hypersensitivity to local anesthetics or to any component of the catheter

• Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).