Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters.
Overview
- Phase
- Phase 2
- Intervention
- Ropivacaine
- Conditions
- Scheduled Cardiac Surgery
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The deadline for obtaining all criteria consistent with an output of postoperative intensive care
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •aortic dissection
- •age over 85
- •pregnancy
- •patient's refusal
- •minor or adult under legal protection
- •psychiatric ongoing disease
- •addiction to opiates
Arms & Interventions
Ropivacaïne
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.
Intervention: Ropivacaine
Placebo
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.
Intervention: placebo
Outcomes
Primary Outcomes
The deadline for obtaining all criteria consistent with an output of postoperative intensive care
Time Frame: 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 Outcomes
- Surgery time(24 hours)
- Quantity of sufentanil administered(72 hours)
- Total morphine consumption(72 hours)