Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-21 @ 1:29 AM
Study NCT ID:
NCT01430520
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2011-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)
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': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D003909', 'term': 'Dexetimide'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, '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': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-04', 'studyFirstSubmitDate': '2011-09-07', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'At 24 hour', 'description': 'Pain during walking at 24 hour after surgery'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '1 week', 'description': 'Pain at rest and during walking the first week after TKA'}, {'measure': 'Cumulated pain scores', 'timeFrame': '1 week', 'description': 'Cumulated pain scores for pain the first week after TKA'}, {'measure': 'Amount of rescue analgesic', 'timeFrame': '1 week', 'description': 'Amount of rescue analgesic the first week after TKA'}, {'measure': 'Side effects', 'timeFrame': '1 week', 'description': 'Side effects the first week after TKA'}, {'measure': 'anxiety, depression, and sleep quality', 'timeFrame': '1 week', 'description': 'Anxiety, depression, and sleep quality - questionnaire - the first week after TKA'}, {'measure': 'Escitalopram level in blood-sample', 'timeFrame': '48 hours', 'description': 'Escitalopram level in blood-sample 48 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. The investigators therefore investigate the effect of Escitalopram as a perioperative analgesic.', 'detailedDescription': 'Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. Patients with high pain catastrophizing are mentally vulnerable and may be sensitive to the effects of Escitalopram.\n\nWe therefore investigate the effect of Escitalopram as a perioperative analgesic in this group of patients where the pain problem is pronounced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary, unilateral total knee arthroplasty (TKA)\n* Age \\> 18 \\> 81\n* Ethnic Danes\n* Score \\> 20 on Pain Catastrophising Scale\n\nExclusion Criteria:\n\n* Medication that causes risk in combination with SSRI (6 month)\n* Treatment for anxiety or depression\n* History of depression or mania\n* Treatment with systemic glucocorticoids (6 month)\n* Treatment with opioids (4 weeks)\n* Alcohol or drug abuse\n* History of malignancy\n* Fertile woman\n* History of epilepsia\n* Treatment with anticoagulants\n* BMI \\> 40\n* Disease affecting central or peripheral nerve function\n* Dementia\n* History of gastrointestinal bleeding\n* History of hepato- or renal insufficiency\n* Allergy to Escitalopram'}, 'identificationModule': {'nctId': 'NCT01430520', 'briefTitle': 'Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'THL-04-11'}, 'secondaryIdInfos': [{'id': '2011-002034-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'H-3-2011-055', 'type': 'REGISTRY', 'domain': 'Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Escitalopram', 'interventionNames': ['Drug: Escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Cipralex'], 'description': 'Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery', 'armGroupLabels': ['Escitalopram']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Gentofte Municipality', 'state': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '7500', 'city': 'Holstebro', 'state': 'Holstebro', 'country': 'Denmark', 'facility': 'Regionshospitalet Holstebro', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}, {'zip': '7100', 'city': 'Vejle', 'state': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Sygehus', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Torben B Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regionshospitalet Holstebro'}, {'name': 'Henrik Kehlet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Per W Kristensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vejle Sygehus'}, {'name': 'Søren Solgaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital'}, {'name': 'Vibe G Frøkjær, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PHD', 'investigatorFullName': 'Troels Haxholdt Lunn', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}