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

Scheduled Cardiac Surgery Clinical Trial

— Pre-BLS-Sterno  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495504
• Other study ID #: Pré-BLS-Sterno-RBHP 2018 ELJEZ
• Status: Completed
• Phase: Phase 2
• Start date: July 22, 2020
• Est. completion date: July 12, 2021

Study information

• Verified date: December 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Age Under 85 Years
• Scheduled Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire	Clermont-Ferrand	Puy De Dôme

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Opioid consumption	The technique is considered as a fail if morphine consumption > 35 mg	Day 2 postoperatively.
Secondary	ICU length of stay	Days of ICU and hospital stay	Up to 6 months
Secondary	Hospital length of stay	Days of ICU and hospital stay	Up to 6 months
Secondary	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.
Secondary	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.
Secondary	Respiratory complications	Occurrence of postoperative respiratory complications	Up to 6 months
Secondary	Cardiac complications	Occurrence of postoperative cardiac complications	Up to 6 months
Secondary	Neurological complications	Occurrence of postoperative neurological complications	Up to 6 months
Secondary	Renal,complications	Occurrence of postoperative renal complications	Up to 6 months
Secondary	Infectious complications	Occurrence of postoperative infectious complications	Up to 6 months
Secondary	Chronic pain evaluation	Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score	Assessed at the 6th postoperative month