Age Under 85 Years, Scheduled Cardiac Surgery
Conditions
Keywords
Postoperative analgesia, Sternotomy, Local anesthetics
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 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.
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, prospective, monocentric. One group of patients who will benefits from the placement of two multihole catheters in BLS position: * The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively. * The control group (80 patients) from the two previous studies who underwent standard analgesia with PCA morphine.
Interventions
DRUGRopivacaine
Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation | Day 2 postoperatively. | The technique is considered as a fail if : pain rest \> 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization \> 3.5/10 (0 = no pain; 10 maximum pain) |
| Opioid consumption | Day 2 postoperatively. | The technique is considered as a fail if morphine consumption \> 35 mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | Up to 6 months | Days of ICU and hospital stay |
| Hospital length of stay | Up to 6 months | Days of ICU and hospital stay |
| Patient satisfaction | Day 2 postoperatively. | Patient satisfaction evaluation from the patient based on a simple Likert scale: 0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent. |
| Postoperative nausea and vomiting | Day 1 and 2 postoperatively. | assessed by the Wengritzky intensity scale (if total score \> 50, the nausea and vomiting are clincally significant) |
| Respiratory complications | Up to 6 months | Occurrence of postoperative respiratory complications |
| Cardiac complications | Up to 6 months | Occurrence of postoperative cardiac complications |
| Neurological complications | Up to 6 months | Occurrence of postoperative neurological complications |
| Renal,complications | Up to 6 months | Occurrence of postoperative renal complications |
| Infectious complications | Up to 6 months | Occurrence of postoperative infectious complications |
| Chronic pain evaluation | Assessed at the 6th postoperative month | Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORVedat Eljezi, Dr
Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire
Outcome results
None listed