Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-29 @ 12:21 AM
Study NCT ID:
NCT06233435
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 6 and 24 Hours in Patients Undergoing Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 6 and 24 Hours in Patients Undergoing Total Knee Arthroplasty', 'timeFrame': 'at 6 and 24 hours after total knee arthroplasty'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This study is a prospective study which compares of Modified Post-Anesthetic Discharge Scoring System (PADSS) between 6 and 24 hours in patients undergoing total knee arthroplasty in Thammasat University hospital, Thailand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing total knee arthroplasty (one side) under spinal block with adductor canal block\n* 18-85 years old\n* American Society of Anesthesiologist physical status classification I-III\n\nExclusion Criteria:\n\n* Allergy to local anesthetic drugs'}, 'identificationModule': {'nctId': 'NCT06233435', 'briefTitle': 'Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 6 and 24 Hours in Patients Undergoing Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University Hospital'}, 'officialTitle': 'Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 6 and 24 Hours in Patients Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'MTU-EC-AN-2-179/66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PADSS at 6 hours', 'interventionNames': ['Behavioral: PADSS']}, {'type': 'OTHER', 'label': 'PADSS at 24 hours', 'interventionNames': ['Behavioral: PADSS']}], 'interventions': [{'name': 'PADSS', 'type': 'BEHAVIORAL', 'description': 'Observe PADSS after total knee arthroplasty at 6 and 24 hours', 'armGroupLabels': ['PADSS at 24 hours', 'PADSS at 6 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12120', 'city': 'Pathum Thani', 'state': 'Klong Luang', 'country': 'Thailand', 'facility': 'Thammasat University hospital', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology', 'investigatorFullName': 'Niruji Saengsomsuan', 'investigatorAffiliation': 'Thammasat University'}}}}