Advantage of Tramadol in Local Analgesia Post-Sternotomy (ATLAS)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed

Phase 4

Conditions

Heart Surgery Via Sternotomy

Post-operative Analgesia

Treatments

Drug: Levobupivacaine

Drug: levobupivacaine

Drug: tramadol

Study type

Interventional

Funder types

Other

Identifiers

NCT02851394

Bethenod Ellouze 2014

Details and patient eligibility

About

Sternotomy, the reference approach for heart surgery, may induce profound and intense post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.

The analgesic efficacy of continuous wound infiltration at the sternum following heart surgery has been demonstrated.

The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.

The aim of this study is to determine whether a bolus of tramadol associated with the continuous administration of levobupivacaine via the wound catheter could potentiate the local anaesthetic effects, thus leading to a decreased consumption of postoperative intravenous morphine, and a decrease in morphine-related side effects.

Enrollment

160 patients

Sex

All

Volunteers

No Healthy Volunteers

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