Heart Surgery Via SternotomyPhase 4ATLASNCT02851394
Advantage of Tramadol in Local Analgesia Post-Sternotomy
A Phase 4 study testing Levobupivacaine and tramadol in people with Heart Surgery Via Sternotomy and Post-operative Analgesia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Surgery Via Sternotomy, Post-operative Analgesia
- What is being tested?
- Levobupivacaine and tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Being tested
- Levobupivacaine, tramadol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
levobupivacaineDrug
tramadolDrug
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine group | Active comparator | Not described Receives: Drug: Levobupivacaine |
| Levobupivacaine + tramadol group | Experimental | Not described Receives: Drug: levobupivacaine; Drug: tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of morphine, expressed in milligrams, in the post-operative period
Measured: 48 hour after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Surgery Via SternotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851394
- Sponsor's protocol ID
- Bethenod Ellouze 2014
- Acronym
- ATLAS
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
Bethenod F, Ellouze O, Berthoud V, Missaoui A, Cransac A, Aho S, Bouchot O, Girard C, Guinot PG, Bouhemad B. A single dose of tramadol in continuous wound analgesia with levobupivacaine does not reduce post-sternotomy pain: a randomized controlled trial. J Pain Res. 2019 Sep 18;12:2733-2741. doi: 10.2147/JPR.S211042. eCollection 2019.
PubMed 31571977