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

NCT04495504 | Completed Phase 2

• 1 other identifier: Pré-BLS-Sterno-RBHP 2018 ELJEZ
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Scheduled Cardiac Surgery; Age Under 85 Years

Keywords

Postoperative analgesia; Sternotomy; Local anesthetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• ICU length of stay

  Up to 6 months

• Hospital length of stay

  Up to 6 months

• Patient satisfaction

  Day 2 postoperatively.

• Postoperative nausea and vomiting

  Day 1 and 2 postoperatively.

• Respiratory complications

  Up to 6 months

Study Arms (1)

Ropivacaine group

EXPERIMENTAL

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

Drug: Ropivacaine

Interventions

Ropivacaine 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.

Ropivacaine group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire

Clermont-Ferrand, Puy De Dôme, 63000, France

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Vedat Eljezi, Dr

  Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 3, 2020
• Study Start: July 22, 2020
• Primary Completion: January 12, 2021
• Study Completion: July 12, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

FR (1)