Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT01191593
Status:
COMPLETED
Last Update Posted:
2013-08-22
First Post:
2010-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'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'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-21', 'studyFirstSubmitDate': '2010-08-30', 'studyFirstSubmitQcDate': '2010-08-30', 'lastUpdatePostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain during 45 degrees active flexion of the knee', 'timeFrame': '4 hours postoperative', 'description': '0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.'}], 'secondaryOutcomes': [{'measure': 'Pain during 45 degrees active flexion of the knee', 'timeFrame': '1-8 hours postoperative', 'description': '0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.'}, {'measure': 'Pain during 45 degrees active flexion of the knee', 'timeFrame': '24 hours postoperative', 'description': '0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.'}, {'measure': 'Pain during rest', 'timeFrame': '1-8 hours postoperative', 'description': '0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.'}, {'measure': 'Pain during rest', 'timeFrame': '24 hours postoperative', 'description': '0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.'}, {'measure': 'Total morphine consumption', 'timeFrame': '0-24 hours postoperative', 'description': 'Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.'}, {'measure': 'Postoperative nausea', 'timeFrame': '1-8 hours postoperative', 'description': 'Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.'}, {'measure': 'Postoperative nausea', 'timeFrame': '24 hours postoperative', 'description': 'Nausea score(0-3)at 24 hours postoperative.'}, {'measure': 'Postoperative vomiting', 'timeFrame': '0-24 hours postoperative', 'description': 'Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.'}, {'measure': 'Zofran consumption', 'timeFrame': '0-24 hours postoperative', 'description': 'Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.'}, {'measure': 'Sedation', 'timeFrame': '1-8 hours postoperative', 'description': 'Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.'}, {'measure': 'Sedation', 'timeFrame': '24 hours postoperative', 'description': 'Sedation score (0-3) at 24 hours postoperative.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adductor-Canal-Blockade', 'postoperative pain', 'US-guided nerve block', 'revision knee arthroplasty'], 'conditions': ['Postoperative Pain', 'Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '25386752', 'type': 'DERIVED', 'citation': 'Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Revision Knee Arthroplasty in general anaesthesia\n* American society of anesthesiologists (ASA) 1-3\n* BMI 18-40\n* Written informed consent\n\nExclusion Criteria:\n\n* Can not cooperate to the exam\n* Do not speak or understand Danish\n* Drug allergy\n* Alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT01191593', 'briefTitle': 'The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'SM1-PJ-10'}, 'secondaryIdInfos': [{'id': '2010-021161-71', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adductor-Canal-Blockade with ropivacaine', 'interventionNames': ['Procedure: Adductor-Canal-Blockade with Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Adductor-Canal-blockade with saline', 'interventionNames': ['Procedure: Adductor-Canal-blockade with saline']}], 'interventions': [{'name': 'Adductor-Canal-Blockade with Ropivacaine', 'type': 'PROCEDURE', 'otherNames': ['Naropine', 'Postoperative pain', 'US-guided nerve block'], 'description': 'US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml', 'armGroupLabels': ['Adductor-Canal-Blockade with ropivacaine']}, {'name': 'Adductor-Canal-blockade with saline', 'type': 'PROCEDURE', 'otherNames': ['Placebo block'], 'description': 'US-guided Adductor-Canal-blockade with saline', 'armGroupLabels': ['Adductor-Canal-blockade with saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'København Ø', 'country': 'Denmark', 'facility': 'Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Pia Jæger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Pia Jaeger', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}