Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-31 @ 3:35 AM
Study NCT ID:
NCT03865550
Status:
UNKNOWN
Last Update Posted:
2019-03-07
First Post:
2019-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-op Ketamine Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-04-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain as reported on Visual Analog Scale', 'timeFrame': 'Up to 6 weeks post-operatively', 'description': 'VAS pain reported 0-100mm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 85 years of age\n* ASA I - IV\n* Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia\n\nExclusion Criteria:\n\n* BMI over 40\\*\n* Contraindication or allergy to opioid pain medication or ketamine\\*\n* Daily opioid use for pain control before surgery in excess of systemic morphine equivalent to 10 mg\\*\n* Ejection fraction (EF) less than 30%\n* Creatinine clearance less than 30 mL/min\\*\n* History of chronic liver failure\n* Desire for nerve block or general anesthesia\n* Any neurologic or psychiatric disorder (including bipolar disorder, post traumatic stress disorder, schizophrenia)\n* Prior surgery on ipsilateral knee within the last 6 months\n* Alcohol abuse'}, 'identificationModule': {'nctId': 'NCT03865550', 'briefTitle': 'Post-op Ketamine Study', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia', 'orgStudyIdInfo': {'id': '2016Levicoff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Isotonic saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine', 'interventionNames': ['Drug: Ketamine Injectable Solution']}], 'interventions': [{'name': 'Isotonic saline', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Ketamine Injectable Solution', 'type': 'DRUG', 'description': 'Active comparator', 'armGroupLabels': ['Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}