Advantage of Tramadol in Local Analgesia Post-Sternotomy
NCT ID: NCT02851394
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2015-10-31
2016-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Levobupivacaine group
Levobupivacaine
Levobupivacaine + tramadol group
levobupivacaine
tramadol
Interventions
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Levobupivacaine
levobupivacaine
tramadol
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon Bourgogne
Dijon, , France
Countries
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References
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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.
Other Identifiers
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Bethenod Ellouze 2014
Identifier Type: -
Identifier Source: org_study_id