Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 6:10 PM
Study NCT ID:
NCT01196767
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2010-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropivacaine Though Laterosternal Catheters After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D002404', 'term': 'Catheterization'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-02', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.', 'timeFrame': 'every 4 hours during 48 hours'}], 'secondaryOutcomes': [{'measure': 'Morphine consumption on PCA device', 'timeFrame': 'every 4 hours during 48 hours'}, {'measure': 'Pain score at rest, expressed on a visual analogue scale.', 'timeFrame': 'every 4 hours during 48 hours'}, {'measure': 'Vital capacity and inspiratory reserve volume, related to the preoperative values', 'timeFrame': 'daily during 48 hours'}, {'measure': 'Postoperative blood level of troponin', 'timeFrame': 'every 8 hours during 48 hours'}, {'measure': 'Arterial blood gases', 'timeFrame': 'every 4 hours during 48 hours'}, {'measure': 'Time to first flatus', 'timeFrame': 'daily during 48 hours'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'daily during 48 hours', 'description': 'nausea and vomiting, pruritus'}, {'measure': 'Postoperative blood level of ropivacaine at day + 1 and day + 2', 'timeFrame': 'daily during 48 hours'}, {'measure': 'Signs of intoxication to ropivacaine', 'timeFrame': 'eventual reports'}]}, 'conditionsModule': {'keywords': ['Sternotomy', 'Pain', 'Respiratory function', 'Opiates', 'Patient-controlled', 'Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied'], 'conditions': ['Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '22266899', 'type': 'RESULT', 'citation': 'Eljezi V, Duale C, Azarnoush K, Skrzypczak Y, Sautou V, Pereira B, Tsokanis I, Schoeffler P. The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):166-74. doi: 10.1097/AAP.0b013e318240957f.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22266899', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.', 'detailedDescription': 'Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled cardiac surgery.\n\nExclusion Criteria:\n\n* \\- surgery in emergency\n* thoracotomy\n* cardiac graft\n* redo\n* pregnancy\n* patient's refusal\n* minor or adult under legal protection\n* psychiatric ongoing disease\n* addiction to opiates\n* ongoing opiate treatment\n* inability to use a PCA device\n* respiratory insuffiency (Vital capacity or maximal expired volume per sec. \\< 50% of the expected value, or mean PAP \\> 50 mmHg)\n* intra-aortic balloon\n* severe renal insuffiency\n* history of allergy or intolerance to: morphine, acetaminophen, bupivacaine."}, 'identificationModule': {'nctId': 'NCT01196767', 'briefTitle': 'Ropivacaine Though Laterosternal Catheters After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters', 'orgStudyIdInfo': {'id': 'CHU-0080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ropivacaine', 'interventionNames': ['Drug: Ropivacaine (in one arm); catheterization (in both).']}, {'type': 'OTHER', 'label': 'normal saline', 'interventionNames': ['Drug: Ropivacaine (in one arm); catheterization (in both).']}], 'interventions': [{'name': 'Ropivacaine (in one arm); catheterization (in both).', 'type': 'DRUG', 'description': 'Parallel study with two groups:\n\n1. ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump.\n2. same protocol, with normal saline instead of ropivacaine.', 'armGroupLabels': ['normal saline', 'ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Vedat Eldjezi, MB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}