Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT01364194
Status:
COMPLETED
Last Update Posted:
2011-06-02
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement
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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-01', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': '96 hour post operation', 'description': 'Measure by Visual analog scale scores and morphine consumption'}], 'secondaryOutcomes': [{'measure': 'Complication of Morphine consumption', 'timeFrame': '96 hour post operation', 'description': 'nausea, pruritis, urinary retention and constipation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post operative pain', 'Total knee replacement', 'Total knee arthroplasty', 'Bupivacaine', 'Periarticular injection', 'Placebo', 'Morphine consumption'], 'conditions': ['Pain, Postoperative', 'Arthropathy of Knee Joint']}, 'referencesModule': {'references': [{'pmid': '16134568', 'type': 'BACKGROUND', 'citation': 'Mehrotra C, Remington PL, Naimi TS, Washington W, Miller R. Trends in total knee replacement surgeries and implications for public health, 1990-2000. Public Health Rep. 2005 May-Jun;120(3):278-82. doi: 10.1177/003335490512000310.'}, {'pmid': '19339865', 'type': 'BACKGROUND', 'citation': 'Akyol O, Karayurt O, Salmond S. Experiences of pain and satisfaction with pain management in patients undergoing total knee replacement. Orthop Nurs. 2009 Mar-Apr;28(2):79-85. doi: 10.1097/NOR.0b013e3181945f62.'}, {'pmid': '9661552', 'type': 'BACKGROUND', 'citation': 'Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.'}, {'pmid': '17464603', 'type': 'BACKGROUND', 'citation': 'Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen EK, Soballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. doi: 10.1080/17453670710013645.'}, {'pmid': '16452738', 'type': 'BACKGROUND', 'citation': 'Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.'}, {'pmid': '17823012', 'type': 'BACKGROUND', 'citation': 'Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.'}, {'pmid': '16651569', 'type': 'BACKGROUND', 'citation': 'Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.'}], 'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/kneereplacement.html', 'label': 'Total knee replacement'}, {'url': 'http://www.rxlist.com/marcaine-drug.htm', 'label': 'Bupivacaine information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care.', 'detailedDescription': 'Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital\n* BMI between 20-35\n* having a full understanding of the question in this trial\n\nExclusion Criteria:\n\n* allergy to NSAIDs, Acetaminophen, Bupivacaine\n* blood creatinine more than 1.5 mg/dl or creatinine clearance less than 60 mL/min\n* abnormal liver function\n* previous surgery on the knee undergoing total knee replacement\n* patient could not receive spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT01364194', 'briefTitle': 'Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial', 'orgStudyIdInfo': {'id': '516/2552(EC3)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.25% Bupivacaine', 'description': 'Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.', 'interventionNames': ['Drug: 0.25% Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% normal saline', 'description': 'Periarticular injection with 20 ml of 0.9% normal saline before wound closure.', 'interventionNames': ['Drug: 0.9% normal saline']}], 'interventions': [{'name': '0.25% Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.', 'armGroupLabels': ['0.25% Bupivacaine']}, {'name': '0.9% normal saline', 'type': 'DRUG', 'otherNames': ['Isotonic saline'], 'description': 'Periarticular injection with 20 ml of 0.9% normal saline before wound closure.', 'armGroupLabels': ['0.9% normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital'}], 'overallOfficials': [{'name': 'Keerati Chareancholvanich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siriraj Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Keerati Chareancholvanich, MD', 'oldOrganization': 'Siriraj Hospital, Mahidol University'}}}}