Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-26 @ 9:16 PM
Study NCT ID:
NCT03434951
Status:
UNKNOWN
Last Update Posted:
2018-02-15
First Post:
2017-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty
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'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2017-12-10', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intravenous oxycodone consumption', 'timeFrame': '48 hours', 'description': 'Cumulative postoperative consumption'}], 'secondaryOutcomes': [{'measure': 'Adverse effects of 0,2mg intrathecal morphine', 'timeFrame': '48 hours', 'description': 'Possible nausea, vomiting, itching and respiratory depression'}, {'measure': 'Mobilization time', 'timeFrame': '48 hours', 'description': 'Assessing the time to ambulation'}, {'measure': 'Patient satisfaction', 'timeFrame': '28 days', 'description': 'Telephone interview 28 days after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective primary total knee arthroplasty\n* ASA I-III\n* written consent\n\nExclusion Criteria:\n\n* rearthroplasty\n* ASA IV-V\n* inadequate spoken finnish for reliable pain assessment\n* Dementia or otherwise impaired cognition\n* contraindication for any medication or substance used in survey protocol\n* weight \\<50kg or BMI ≥35 kg/m2\n* preoperative SpO2 less than 93%\n* clinical suspicion that subject can not use PCA adequately\n* history of substance abuse or current excessive use of alcohol\n* preoperative use of either pregabalin, gabapentin or strong opiates'}, 'identificationModule': {'nctId': 'NCT03434951', 'briefTitle': 'Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'South Carelia Central Hospital'}, 'officialTitle': 'Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'KNEMO 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrathecal morphine and bupivacaine', 'description': '0,2mg intrathecal morphine and 12,5mg bupivacaine administered', 'interventionNames': ['Drug: Bupivacaine Hydrochloride, Spinal', 'Drug: Morphine hydrochloride, Spinal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': '12,5mg bupivacaine and NaCl 0,9% to match the same volume administered', 'interventionNames': ['Drug: Bupivacaine Hydrochloride, Spinal', 'Drug: Placebo - Concentrate']}], 'interventions': [{'name': 'Bupivacaine Hydrochloride, Spinal', 'type': 'DRUG', 'description': 'Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia', 'armGroupLabels': ['Intrathecal morphine and bupivacaine', 'Placebo']}, {'name': 'Morphine hydrochloride, Spinal', 'type': 'DRUG', 'description': 'Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)', 'armGroupLabels': ['Intrathecal morphine and bupivacaine']}, {'name': 'Placebo - Concentrate', 'type': 'DRUG', 'otherNames': ['physiologic saline solution'], 'description': 'Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53130', 'city': 'Lappeenranta', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Susanna Niinimäki, BSc, SRN /Anesthesia', 'role': 'CONTACT', 'email': 'Susanna.niinimaki@eksote.fi', 'phone': '+358406511388'}, {'name': 'MD, PhD', 'role': 'CONTACT'}], 'facility': 'South Carelia Central Hospital', 'geoPoint': {'lat': 61.05871, 'lon': 28.18871}}], 'centralContacts': [{'name': 'Susanna Niinimäki, BSc, SRN /Anesthesia', 'role': 'CONTACT', 'email': 'susanna.niinimaki@eksote.fi', 'phone': '+358406511388'}, {'name': 'Seppo Mustola, MD, PhD', 'role': 'CONTACT', 'email': 'seppo.mustola@eksote.fi', 'phone': '+358447915832'}], 'overallOfficials': [{'name': 'Seppo Mustola, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'South Carelia Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Carelia Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SRN/ Anesthesia', 'investigatorFullName': 'Susanna Niinimäki', 'investigatorAffiliation': 'South Carelia Central Hospital'}}}}