Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery (Pre-BLS-Sterno)

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

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.

Study Overview

• Status: Completed
• Conditions: Scheduled Cardiac Surgery; Age Under 85 Years
• Intervention / Treatment: Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Puy De Dôme
    • Clermont-Ferrand, Puy De Dôme, France, 63000
      • CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine group; Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation	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)	Day 2 postoperatively.
Opioid consumption	The technique is considered as a fail if morphine consumption > 35 mg	Day 2 postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	Days of ICU and hospital stay	Up to 6 months
Hospital length of stay	Days of ICU and hospital stay	Up to 6 months
Patient satisfaction	Patient satisfaction evaluation from the patient based on a simple Likert scale: 0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.	Day 2 postoperatively.
Postoperative nausea and vomiting	assessed by the Wengritzky intensity scale (if total score > 50, the nausea and vomiting are clincally significant)	Day 1 and 2 postoperatively.
Respiratory complications	Occurrence of postoperative respiratory complications	Up to 6 months
Cardiac complications	Occurrence of postoperative cardiac complications	Up to 6 months
Neurological complications	Occurrence of postoperative neurological complications	Up to 6 months
Renal,complications	Occurrence of postoperative renal complications	Up to 6 months
Infectious complications	Occurrence of postoperative infectious complications	Up to 6 months
Chronic pain evaluation	Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score	Assessed at the 6th postoperative month

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Vedat Eljezi, Dr, Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): January 12, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative analgesia; Sternotomy; Local anesthetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Pré-BLS-Sterno-RBHP 2018 ELJEZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No