Status:
COMPLETED
Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Scheduled Cardiac Surgery
Age Under 85 Years
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 significant...
Detailed Description
Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint (pain at rest, pain during patient mobilization and opioid consumption). Open trial, therapeutic, prospecti...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04495504
Start Date
July 22 2020
End Date
July 12 2021
Last Update
December 5 2022
Active Locations (1)
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1
CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire
Clermont-Ferrand, Puy De Dôme, France, 63000