Status:
COMPLETED
Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Scheduled Cardiac Surgery
Sternotomy
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of cou...
Detailed Description
Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two m...
Eligibility Criteria
Inclusion
- Scheduled cardiac surgery (aortic or mitral valve replacement, or coronary bypass surgery) with sternotomy.
- Patients will be at risk of noncardiac postoperative complications, i.e. age over 75, BMI over 30, pulmonary disease, or active smoking habit
Exclusion
- surgery in emergency
- thoracotomy
- cardiac graft
- redo
- aortic dissection
- age over 85
- pregnancy
- patient's refusal
- minor or adult under legal protection
- psychiatric ongoing disease
- addiction to opiates
- ongoing opiate treatment
- inability to use a PCA device
- respiratory insufficiency (Vital capacity or maximal expired volume per sec. \< 50% of the expected value, or mean PAP \> 50 mmHg)
- cardiac failure or EF \< 40% or intra-aortic balloon use
- pulmonary hypertension over 50 mmHg
- severe renal insufficiency
- history of allergy or intolerance to: morphine, acetaminophen, ropivacaine.
Key Trial Info
Start Date :
April 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01828788
Start Date
April 27 2013
End Date
January 19 2015
Last Update
July 5 2018
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003