Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-04-13 @ 4:49 PM
Study NCT ID:
NCT03232957
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Morphine for Unilateral Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical rating scale', 'timeFrame': 'Within 48 hours', 'description': 'Numerical rating scale 0-10'}], 'secondaryOutcomes': [{'measure': 'Morphine requirement', 'timeFrame': 'Within 48 hours', 'description': 'Systemic morphine requirement'}, {'measure': 'Nausea vomiting', 'timeFrame': 'Within 48 hours', 'description': 'Incidence and severity of nausea and vomiting'}, {'measure': 'Pruritus', 'timeFrame': 'Within 48 hours', 'description': 'Incidence and severity of pruritus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intrathecal morphine, total knee arthroplasty'], 'conditions': ['Primary Osteoarthritis of Knee Nos']}, 'referencesModule': {'references': [{'pmid': '25550024', 'type': 'BACKGROUND', 'citation': 'Stowers MD, Lemanu DP, Coleman B, Hill AG, Munro JT. Review article: Perioperative care in enhanced recovery for total hip and knee arthroplasty. J Orthop Surg (Hong Kong). 2014 Dec;22(3):383-92. doi: 10.1177/230949901402200324.'}, {'pmid': '14570664', 'type': 'BACKGROUND', 'citation': 'Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-1457. doi: 10.1213/01.ANE.0000083374.44039.9E.'}, {'pmid': '24025284', 'type': 'BACKGROUND', 'citation': 'Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435.'}, {'pmid': '18816386', 'type': 'BACKGROUND', 'citation': 'Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.'}, {'pmid': '24403757', 'type': 'BACKGROUND', 'citation': 'Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.'}, {'pmid': '24399578', 'type': 'BACKGROUND', 'citation': 'McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y.'}, {'pmid': '24765899', 'type': 'BACKGROUND', 'citation': 'Kunopart M, Chanthong P, Thongpolswat N, Intiyanaravut T, Pethuahong C. Effects of single shot femoral nerve block combined with intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after total knee arthroplasty. J Med Assoc Thai. 2014 Feb;97(2):195-202.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.', 'detailedDescription': 'Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration.\n\nThis study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged more than 18 years old undergoing unilateral total knee arthroplasty\n* American Society of Anesthesiologists physical status classification 1-3\n\nExclusion Criteria:\n\n* Participants deny to enroll the study\n* Allergy to local anesthetics, opioid and NSAIDs\n* Hepatic disease\n* Contraindication for neuraxial block or adductor canal block\n* Uncontrolled cardiovascular disease\n* Creatinine clearance less than 50 ml/min'}, 'identificationModule': {'nctId': 'NCT03232957', 'briefTitle': 'Intrathecal Morphine for Unilateral Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'Si 331/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No IT morphine', 'description': 'Spinal block with 0.5% isobaric with no intrathecal morphine', 'interventionNames': ['Procedure: No IT morphine', 'Drug: Morphine', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': '50 ug IT morphine', 'description': 'Spinal block with 0.5% isobaric with 50 ug intrathecal morphine', 'interventionNames': ['Procedure: 50 ug IT morphine', 'Drug: Morphine', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': '100 ug IT morphine', 'description': 'Spinal block with 0.5% isobaric with 100 ug intrathecal morphine', 'interventionNames': ['Procedure: 100 ug IT morphine', 'Drug: Morphine', 'Drug: Bupivacaine']}], 'interventions': [{'name': '50 ug IT morphine', 'type': 'PROCEDURE', 'description': 'Spinal block with bupivacaine and intrathecal morphine 50 ug', 'armGroupLabels': ['50 ug IT morphine']}, {'name': '100 ug IT morphine', 'type': 'PROCEDURE', 'description': 'Spinal block with bupivacaine and intrathecal morphine 100 ug', 'armGroupLabels': ['100 ug IT morphine']}, {'name': 'No IT morphine', 'type': 'PROCEDURE', 'description': 'Spinal block with bupivacaine and intrathecal morphine 0 ug', 'armGroupLabels': ['No IT morphine']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'intrathecal morphine', 'armGroupLabels': ['100 ug IT morphine', '50 ug IT morphine', 'No IT morphine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': '0.5 isobaric bupivacaine', 'armGroupLabels': ['100 ug IT morphine', '50 ug IT morphine', 'No IT morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok Noi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}], 'overallOfficials': [{'name': 'Suwimon Tangwiwat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor, Department of Anesthesiology', 'investigatorFullName': 'Suwimon Tangwiwat', 'investigatorAffiliation': 'Mahidol University'}}}}