Scheduled Cardiac Surgery Clinical Trial
— Pre-BLS-SternoOfficial title:
The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
Verified date | December 2022 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire | Clermont-Ferrand | Puy De Dôme |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01828788 -
Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters
|
Phase 2 |