Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT03696095
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2018-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of unplanned analgesia interventions.', 'timeFrame': 'up to 72 hours after surgery', 'description': 'Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period.'}], 'secondaryOutcomes': [{'measure': 'Pain difference', 'timeFrame': 'up to 72 hours after surgery', 'description': 'Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement.'}, {'measure': 'Motor block frequency', 'timeFrame': 'up to 72 hours after surgery', 'description': 'Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.'}, {'measure': 'Mobilization quality during physiotherapy sessions.', 'timeFrame': 'up to 72 hours after surgery', 'description': 'accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee).'}, {'measure': 'local anesthesia technique related complications', 'timeFrame': 'until catheter removal 48 hours after surgery', 'description': 'rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'postoperative pain', 'programmed intermittent bolus', 'Continuous femoral nerve block'], 'conditions': ['Postoperative Pain', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.', 'detailedDescription': 'This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted for unilateral primary total knee arthroplasty.\n\nExclusion Criteria:\n\n* ASA score \\> 3\n* BMI \\> 40\n* refusal of loco-regional technique.\n* psychiatric disease.\n* inability to understand/ use the Local anesthetic delivery pump.\n* local anesthetic allergy,\n* porphyry,\n* uncontrolled epilepsy,\n* severe cardiac arrhythmia.'}, 'identificationModule': {'nctId': 'NCT03696095', 'briefTitle': 'Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.', 'orgStudyIdInfo': {'id': '2018-000822-70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continous infusion ropivacaine', 'description': 'Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ...', 'interventionNames': ['Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)']}, {'type': 'EXPERIMENTAL', 'label': 'PIB ropivacaine', 'description': 'Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ...', 'interventionNames': ['Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)']}], 'interventions': [{'name': 'Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)', 'type': 'DRUG', 'otherNames': ['PIB'], 'description': 'programmed intermittent bolus 5ml each one hour.', 'armGroupLabels': ['PIB ropivacaine']}, {'name': 'Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)', 'type': 'DRUG', 'otherNames': ['Continuous infusion'], 'description': 'continuous infusion 6ml/h', 'armGroupLabels': ['Continous infusion ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Annis Orfi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liege'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'J P Lecoq', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'J P Lecoq', 'investigatorAffiliation': 'University of Liege'}}}}