Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01304212
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2011-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Analgesia in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '48 hours postoperatively', 'description': 'Is measured at the time of starting rehabilitation, postoperatively 48 hours using visual analog scale, numerical and categorical verbal pain scale at 12,24 and 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'intraarticular infiltration', 'femoral block'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intervention program for total knee arthroplasty\n* ASA I, II, III\n* over 65 years old\n\nExclusion Criteria:\n\n* ASA \\> III\n* patients who refuse the realization of technical loco-regional anesthesia\n* presence of coagulopathy or impaired hemostatic function\n* BMI \\> 35\n* Serious intraoperative complications\n* patients undergoing bypass and aortic-femoral or femoro popliteal bypass operated leg\n* patients treated for chronic pain diagnosed processes, different knee osteoarthritis'}, 'identificationModule': {'nctId': 'NCT01304212', 'acronym': 'ATR-2011', 'briefTitle': 'Effectiveness of Analgesia in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'ATR-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'femoral block', 'interventionNames': ['Drug: ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'local infiltration + femoral nerve block', 'description': 'Combination of local infiltration with drugs and femoral nerve block', 'interventionNames': ['Drug: morphine ,ketorolac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'several drugs local infiltration', 'interventionNames': ['Drug: several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac', 'Drug: ropivacaine,morphine chloride,epinephrine,ketorolac']}], 'interventions': [{'name': 'several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac', 'type': 'DRUG', 'description': 'This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline', 'armGroupLabels': ['several drugs local infiltration']}, {'name': 'ropivacaine,morphine chloride,epinephrine,ketorolac', 'type': 'DRUG', 'description': 'This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline', 'armGroupLabels': ['several drugs local infiltration']}, {'name': 'ropivacaine', 'type': 'DRUG', 'description': 'The lock is held before starting the operation, viewing with ultrasound and confirmed the femoral nerve with nerve stimulation at an intensity of 0.5 mA and a frequency of 2 Hz Pajunk 50mm needle, patellar flexion. It be administered 30ml of ropivacaine 0.75% (225mg)', 'armGroupLabels': ['femoral block']}, {'name': 'morphine ,ketorolac', 'type': 'DRUG', 'description': 'ultrasound-assisted femoral nerve block is performed and leaks intraoperatively with a 100 ml solution containing: 5 mg of morphine to 0.1% (5ml) +30 mg of ketorolac (1 ml) +96 ml of 0.9% saline.', 'armGroupLabels': ['local infiltration + femoral nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'José Antonio Bernia Gil, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorci Sanitari de Terrassa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Antonio Bernia Gil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD,MD', 'investigatorFullName': 'Jose Antonio Bernia Gil', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}