Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-23 @ 1:10 AM
Study NCT ID:
NCT01549704
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2012-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-08', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in VAS between ACB and placebo during active 45 degrees knee flexion', 'timeFrame': '45 minutes'}], 'secondaryOutcomes': [{'measure': 'Difference in mean VAS between the groups during active knee flexion', 'timeFrame': '15, 30, 60, 75 and 90 minutes'}, {'measure': 'Difference in mean VAS between the groups at rest', 'timeFrame': '15, 30, 60, 75 and 90 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total knee arthroplasty', 'Adductor canal blockade (ACB)', 'High pain responders', 'US-guided nerve block'], 'conditions': ['Pain After Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '24401802', 'type': 'DERIVED', 'citation': 'Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS \\> 60 during knee flexion the 1. or 2. day after surgery.', 'detailedDescription': 'The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS \\> 60 during active 45 degrees knee flexion will be asked to participate.\n\nIncluded patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TKA within 48 hours and VAS\\>60 during active 45 degrees knee flexion despite conventional pain medication.\n* Informed consent\n* ASA 1-3\n* BMI 18-40\n\nExclusion Criteria:\n\n* Unable to communicate in Danish\n* Allergic reactions toward drugs used in the\n* Abuse of alcohol/drugs\n* Unable to cooperate'}, 'identificationModule': {'nctId': 'NCT01549704', 'briefTitle': 'Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'SM1-UG-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm RP', 'description': 'first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml', 'interventionNames': ['Drug: Ropivacaine', 'Drug: Saline']}, {'type': 'OTHER', 'label': 'Arm PR', 'description': 'first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml', 'interventionNames': ['Drug: Ropivacaine', 'Drug: Saline']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'description': 'Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).\n\nArm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.', 'armGroupLabels': ['Arm PR', 'Arm RP']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['NaCl, placebo'], 'description': 'please see intervention description for ropivacaine', 'armGroupLabels': ['Arm PR', 'Arm RP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Ulrik Grevstad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Ulrik Grevstad', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}