Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-11 @ 9:13 PM
Study NCT ID:
NCT02851394
Status:
COMPLETED
Last Update Posted:
2017-10-10
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advantage of Tramadol in Local Analgesia Post-Sternotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption of morphine, expressed in milligrams, in the post-operative period', 'timeFrame': '48 hour after extubation'}]}, 'conditionsModule': {'conditions': ['Heart Surgery Via Sternotomy', 'Post-operative Analgesia']}, 'referencesModule': {'references': [{'pmid': '31571977', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe analgesic efficacy of continuous wound infiltration at the sternum following heart surgery has been demonstrated.\n\nThe analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons who have provided written consent\n* Patients over 18 years old\n* Patients undergoing heart surgery via sternotomy: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass graft, aorta surgery\n* Patients undergoing emergency or scheduled surgery\n\nExclusion Criteria:\n\n* Adults under guardianship\n* Persons without national health insurance cover\n* Pregnant or breast-feeding women\n* Patients already included in the study once\n* Patients with aortic dissection\n* Patients with mediastinitis or sternal nonunion\n* Patients undergoing heart surgery for the second or more time\n* Patients with local infection or generalized bacteraemia-type infection\n* Patients with hypersensitivity to local anaesthetics or to tramadol or to opiates or to one of the excipients present in the products used\n* Patients with hypersensitivity to paracetamol or to paracetamol hydrochloride (prodrug of paracetamol)\n* Patients on antidepressants, gabapentin, pregabalin, neuroleptics\n* Patients with a history of convulsions or epilepsy\n* Patients with preoperative cognitive dysfunction\n* Patients with intracranial hypertension\n* Chronic use of morphines or high-dose steroid or non-steroid anti-inflammatory agents\n* Patients with acute or chronic kidney failure (creatininemia \\> 170 µmol/L)\n* Patients with liver failure or porphyria\n* Patients under 17 years old\n* Patients with severe respiratory failure\n* Patients treated with a non-selective MAOI (iproniazid), a selective MAOI A (moclobemid, toloxatone), selective MAO-B inhibitor (Selegiline) or linezolid (Zyvoxid®)\n* Patients with acute intoxication or an overdose of products that depress the central nervous system (alcohol, hypnotics, other analgesics…)\n* Patients with severe hypotension'}, 'identificationModule': {'nctId': 'NCT02851394', 'acronym': 'ATLAS', 'briefTitle': 'Advantage of Tramadol in Local Analgesia Post-Sternotomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Bethenod Ellouze 2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine group', 'interventionNames': ['Drug: Levobupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Levobupivacaine + tramadol group', 'interventionNames': ['Drug: levobupivacaine', 'Drug: tramadol']}], 'interventions': [{'name': 'Levobupivacaine', 'type': 'DRUG', 'armGroupLabels': ['Levobupivacaine group']}, {'name': 'levobupivacaine', 'type': 'DRUG', 'armGroupLabels': ['Levobupivacaine + tramadol group']}, {'name': 'tramadol', 'type': 'DRUG', 'armGroupLabels': ['Levobupivacaine + tramadol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}