Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-25 @ 5:16 AM
Study NCT ID:
NCT01636869
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2012-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-25', 'studyFirstSubmitDate': '2012-07-05', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'bupivacaine toxicity', 'timeFrame': '24 hr'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bupivacaine level', 'periarticular block', 'total knee arthroplasty'], 'conditions': ['Serum Bupivacaine Level', 'Periarticular Block', 'Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age of 30-70 yr\n* ASA I-II\n* patient undergo total knee arthroplasty under spinal block and single shot femoral nerve block and periarticular block\n\nExclusion Criteria:\n\n* patient's refusal\n* allergic to bupivacaine\n* body weight less than 50 kg\n* liver disease\n* heart disease\n* coagulopathy\n* Hct\\<35%\n* infection at both groin"}, 'identificationModule': {'nctId': 'NCT01636869', 'briefTitle': 'Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Plasma Concentrations of Bupivacaine After Spinal Anesthesia With Single Shot Femoral Nerve Block and Peri-articular Injection in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '010/2555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bupicavaine', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': '20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation.\n\nBlood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block.', 'armGroupLabels': ['bupicavaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'instructor', 'investigatorFullName': 'Saowaphak Lapmahapaisan', 'investigatorAffiliation': 'Mahidol University'}}}}