Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02851394
Eligibility Criteria:
Inclusion Criteria:
* Persons who have provided written consent
* Patients over 18 years old
* Patients undergoing heart surgery via sternotomy: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass graft, aorta surgery
* Patients undergoing emergency or scheduled surgery
Exclusion Criteria:
* Adults under guardianship
* Persons without national health insurance cover
* Pregnant or breast-feeding women
* Patients already included in the study once
* Patients with aortic dissection
* Patients with mediastinitis or sternal nonunion
* Patients undergoing heart surgery for the second or more time
* Patients with local infection or generalized bacteraemia-type infection
* Patients with hypersensitivity to local anaesthetics or to tramadol or to opiates or to one of the excipients present in the products used
* Patients with hypersensitivity to paracetamol or to paracetamol hydrochloride (prodrug of paracetamol)
* Patients on antidepressants, gabapentin, pregabalin, neuroleptics
* Patients with a history of convulsions or epilepsy
* Patients with preoperative cognitive dysfunction
* Patients with intracranial hypertension
* Chronic use of morphines or high-dose steroid or non-steroid anti-inflammatory agents
* Patients with acute or chronic kidney failure (creatininemia \> 170 µmol/L)
* Patients with liver failure or porphyria
* Patients under 17 years old
* Patients with severe respiratory failure
* Patients treated with a non-selective MAOI (iproniazid), a selective MAOI A (moclobemid, toloxatone), selective MAO-B inhibitor (Selegiline) or linezolid (Zyvoxid®)
* Patients with acute intoxication or an overdose of products that depress the central nervous system (alcohol, hypnotics, other analgesics…)
* Patients with severe hypotension
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02851394
Study Brief:
Protocol Section:
NCT02851394