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New pain combo could cut morphine use after Open-Heart surgery

NCT ID NCT02851394

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Show the full entry requirements

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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