Advantage of Tramadol in Local Analgesia Post-Sternotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Surgery Via Sternotomy Post-operative Analgesia

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

Tramadol

Drug

Primary outcomes

Consumption of morphine, expressed in milligrams, in the post-operative period

Time frame: 48 hour after extubation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Evaluation Of The Efficacy Of A Bolus Infiltration Of The Anaesthetic Tramadol Associated With Continuous Local Anaesthesia Administered Via A Wound Catheter Following Heart Surgery Via Sternotomy At Dijon Chu Single-Centre, Double-Blind, Randomized, Controlled Clinical Trial

Acronym: ATLAS

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 1, 2016
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.

Completed