CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire
Clermont-Ferrand, Puy De Dôme, 63000, France
NCT Number: NCT04495504
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 2
Clermont-Ferrand, Puy De Dôme, 63000, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 2 postoperatively.
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)
Time frame: Day 2 postoperatively.
The technique is considered as a fail if morphine consumption > 35 mg
Time frame: Up to 6 months
Days of ICU and hospital stay
Time frame: Up to 6 months
Days of ICU and hospital stay
Time frame: Day 2 postoperatively.
Patient satisfaction evaluation from the patient based on a simple Likert scale:
0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.
Time frame: Day 1 and 2 postoperatively.
assessed by the Wengritzky intensity scale (if total score > 50, the nausea and vomiting are clincally significant)
Time frame: Up to 6 months
Occurrence of postoperative respiratory complications
Time frame: Up to 6 months
Occurrence of postoperative cardiac complications
Time frame: Up to 6 months
Occurrence of postoperative neurological complications
Time frame: Up to 6 months
Occurrence of postoperative renal complications
Time frame: Up to 6 months
Occurrence of postoperative infectious complications
Time frame: Assessed at the 6th postoperative month
Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score
University Hospital, Clermont-Ferrand
Other
The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
Acronym: Pre-BLS-Sterno
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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