Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 9:37 AM
Study NCT ID:
NCT04495504
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2020-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain evaluation', 'timeFrame': 'Day 2 postoperatively.', 'description': 'The technique is considered as a fail if : pain rest \\> 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization \\> 3.5/10 (0 = no pain; 10 maximum pain)'}, {'measure': 'Opioid consumption', 'timeFrame': 'Day 2 postoperatively.', 'description': 'The technique is considered as a fail if morphine consumption \\> 35 mg'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': 'Up to 6 months', 'description': 'Days of ICU and hospital stay'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Up to 6 months', 'description': 'Days of ICU and hospital stay'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Day 2 postoperatively.', 'description': 'Patient satisfaction evaluation from the patient based on a simple Likert scale:\n\n0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'Day 1 and 2 postoperatively.', 'description': 'assessed by the Wengritzky intensity scale (if total score \\> 50, the nausea and vomiting are clincally significant)'}, {'measure': 'Respiratory complications', 'timeFrame': 'Up to 6 months', 'description': 'Occurrence of postoperative respiratory complications'}, {'measure': 'Cardiac complications', 'timeFrame': 'Up to 6 months', 'description': 'Occurrence of postoperative cardiac complications'}, {'measure': 'Neurological complications', 'timeFrame': 'Up to 6 months', 'description': 'Occurrence of postoperative neurological complications'}, {'measure': 'Renal,complications', 'timeFrame': 'Up to 6 months', 'description': 'Occurrence of postoperative renal complications'}, {'measure': 'Infectious complications', 'timeFrame': 'Up to 6 months', 'description': 'Occurrence of postoperative infectious complications'}, {'measure': 'Chronic pain evaluation', 'timeFrame': 'Assessed at the 6th postoperative month', 'description': 'Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative analgesia', 'Sternotomy', 'Local anesthetics'], 'conditions': ['Scheduled Cardiac Surgery', 'Age Under 85 Years']}, 'descriptionModule': {'briefSummary': 'The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.', 'detailedDescription': 'Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint (pain at rest, pain during patient mobilization and opioid consumption).\n\nOpen trial, therapeutic, prospective, monocentric. One group of patients who will benefits from the placement of two multihole catheters in BLS position:\n\n* The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.\n* The control group (80 patients) from the two previous studies who underwent standard analgesia with PCA morphine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery\n* Age under 85 years\n* Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code\n* Possession of Social Security insurance.\n\nExclusion Criteria:\n\n* Emergency surgery\n* Approach by thoracotomy\n* Heart transplant\n* Aortic dissection\n* Redo surgery.\n* Pregnant women\n* Refusal of the protocol\n* Protected minors or adults\n* Pre-existing psychiatric pathology including known states of opioid addiction\n* Long-term opioid medication\n* Physical or intellectual inability to use a PCA\n* Severe heart failure (ejection fraction less than 40% or PAH \\> 50 mmHg)\n* Preoperative cardiogenic shock\n* Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula\n* Known hypersensitivity to local anesthetics or to any component of the catheter\n* Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates)."}, 'identificationModule': {'nctId': 'NCT04495504', 'acronym': 'Pre-BLS-Sterno', 'briefTitle': 'Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery', 'orgStudyIdInfo': {'id': 'Pré-BLS-Sterno-RBHP 2018 ELJEZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine group', 'description': 'Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively.', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.', 'armGroupLabels': ['Ropivacaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Puy De Dôme', 'country': 'France', 'facility': 'CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Vedat Eljezi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle Anesthésie Réanimation / Service de Chirurgie Cardio-Vasculaire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}