Chronic Bronchitis, Elderly Patients, Obesity, Scheduled Cardiac Surgery, Sternotomy
Conditions
Keywords
Sternotomy, Anesthesia, Post-operative pain
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 coughing, deep breathing, and early mobilisation. It may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia \[Eljezi et al.. Reg Anesth Pain Med 2012; 37:166\]. Such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.
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 multihole catheters placed lateral to the sternum. In both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.
Interventions
DRUGRopivacaine
DRUGplacebo
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The deadline for obtaining all criteria consistent with an output of postoperative intensive care | 72 hours | The criteria will be considered by an independent adjudication committee unaware of the treatment given, according to a predefined checklist, whatever the actual delay for discharge. The checklist was built with the help of published recommendations \[Camp et al. J Card Surg 2009; 24:414\]. |
Secondary
| Measure | Time frame |
|---|---|
| Surgery time | 24 hours |
| Quantity of sufentanil administered | 72 hours |
| Total morphine consumption | 72 hours |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORVedat Eljezi
University Hospital, Clermont-Ferrand
Outcome results
None listed