Clinical trial NCT04495504: Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
Official title: The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scheduled Cardiac Surgery
Age Under 85 Years
Keywords: Postoperative analgesia
Sternotomy
Local anesthetics
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain evaluation
timeFrame: Day 2 postoperatively.
measure: Opioid consumption
timeFrame: Day 2 postoperatively.
Secondary outcomes:
measure: ICU length of stay
timeFrame: Up to 6 months
measure: Hospital length of stay
timeFrame: Up to 6 months
measure: Patient satisfaction
timeFrame: Day 2 postoperatively.
measure: Postoperative nausea and vomiting
timeFrame: Day 1 and 2 postoperatively.
measure: Respiratory complications
timeFrame: Up to 6 months
measure: Cardiac complications
timeFrame: Up to 6 months
measure: Neurological complications
timeFrame: Up to 6 months
measure: Renal,complications
timeFrame: Up to 6 months
measure: Infectious complications
timeFrame: Up to 6 months
measure: Chronic pain evaluation
timeFrame: Assessed at the 6th postoperative month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire
state: Puy De Dôme
Study officials:
affiliation: Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire
name: Vedat Eljezi, Dr
role: PRINCIPAL_INVESTIGATOR
References: