Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

NCT ID: NCT04495504

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2021-07-12

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.

Conditions

Scheduled Cardiac Surgery; Age Under 85 Years

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ropivacaine group

Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

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.

Interventions

Ropivacaine

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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vedat Eljezi, Dr

Role: PRINCIPAL_INVESTIGATOR

Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire

Locations

CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire

Clermont-Ferrand, Puy De Dôme, France

Countries

France

Other Identifiers

Pré-BLS-Sterno-RBHP 2018 ELJEZ

Identifier Type: -

Identifier Source: org_study_id