New pain combo could cut morphine use after Open-Heart surgery
NCT ID NCT02851394
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether adding a tramadol injection to a continuous local anesthetic (levobupivacaine) delivered through a wound catheter can reduce the need for morphine after heart surgery via sternotomy. 160 adults undergoing various heart surgeries were enrolled. The goal was to see if this approach lowers morphine consumption and related side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tramadol and levobupivacaine
- What this could lead to
- If it works, this could provide a better way to manage pain after heart surgery, reducing the need for morphine and its side effects.
- What could go wrong
- This is a small, single-center Phase 4 trial, so results may not apply broadly. The combination might not significantly reduce morphine use or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
160 people
The number who actually took part.
- Start date
-
Oct 2015
- Finished
-
Oct 2016
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU Dijon Bourgogne
Dijon, 21079, France
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Other studies related to the condition(s) this trial covers.
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