Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT02025634
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2013-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Brad.Homan.MD@AdventHealth.com', 'phone': '407-303-4270', 'title': 'Brad Homan', 'organization': 'AdventHealth'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Acetaminophen', 'description': "Infusion of Intravenous acetaminophen (Ofirmev)\n\nIntravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.", 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (0.9% Normal Saline Infusion)', 'description': 'Infusion of 100 ml of 0.9 NS Normal Saline\n\nPlacebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Pain Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Acetaminophen', 'description': "Infusion of Intravenous acetaminophen (Ofirmev)\n\nIntravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."}, {'id': 'OG001', 'title': 'Placebo (0.9% Normal Saline Infusion)', 'description': 'Infusion of 100 ml of 0.9 NS Normal Saline\n\nPlacebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3160', 'spread': '1.33510', 'groupId': 'OG000'}, {'value': '2.1362', 'spread': '1.59323', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 8 hours', 'description': 'To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Acetaminophen', 'description': "Infusion of Intravenous acetaminophen (Ofirmev)\n\nIntravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."}, {'id': 'OG001', 'title': 'Placebo (0.9% Normal Saline Infusion)', 'description': 'Infusion of 100 ml of 0.9 NS Normal Saline\n\nPlacebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 8 hours', 'description': 'To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.', 'unitOfMeasure': 'mg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room")', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Acetaminophen', 'description': "Infusion of Intravenous acetaminophen (Ofirmev)\n\nIntravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."}, {'id': 'OG001', 'title': 'Placebo (0.9% Normal Saline Infusion)', 'description': 'Infusion of 100 ml of 0.9 NS Normal Saline\n\nPlacebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS'}], 'classes': [{'categories': [{'measurements': [{'value': '3.30', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '5.22'}, {'value': '3.40', 'groupId': 'OG001', 'lowerLimit': '1.23', 'upperLimit': '8.60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 8.6 hours', 'description': 'To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravenous Acetaminophen', 'description': "Infusion of Intravenous acetaminophen (Ofirmev)\n\nIntravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."}, {'id': 'FG001', 'title': 'Placebo (0.9% Normal Saline Infusion)', 'description': 'Infusion of 100 ml of 0.9 NS Normal Saline\n\nPlacebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravenous Acetaminophen', 'description': "Infusion of Intravenous acetaminophen (Ofirmev)\n\nIntravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight."}, {'id': 'BG001', 'title': 'Placebo (0.9% Normal Saline Infusion)', 'description': 'Infusion of 100 ml of 0.9 NS Normal Saline\n\nPlacebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2013-12-30', 'resultsFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-23', 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room")', 'timeFrame': 'up to 8.6 hours', 'description': 'To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen.'}], 'primaryOutcomes': [{'measure': 'Postoperative Pain Levels', 'timeFrame': 'up to 8 hours', 'description': 'To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Opioid Consumption', 'timeFrame': 'up to 8 hours', 'description': 'To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain, Postoperative', 'Ofirmev', 'Acetaminophen', 'Analgesics, Non-Narcotic', 'Arthroscopy'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.', 'detailedDescription': "This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control).\n\nThe PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is scheduled for knee arthroscopy with or without chondroplasty.\n* Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.\n* Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.\n* Is willing and able to sign an informed consent.\n\nExclusion Criteria:\n\n* Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures\n* Has self-reported and/or documented previous hypersensitivity to acetaminophen.\n* Has self-reported and/or documented history of hepatic disease or impairment.\n* Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.\n* Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.\n* Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment of the physician PI/Sub-I.'}, 'identificationModule': {'nctId': 'NCT02025634', 'acronym': 'IVTYLENOL', 'briefTitle': 'Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy', 'orgStudyIdInfo': {'id': '503526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous acetaminophen', 'description': 'Infusion of Intravenous acetaminophen (Ofirmev)', 'interventionNames': ['Drug: Intravenous Acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (0.9% Normal Saline Infusion)', 'description': 'Infusion of 100 ml of 0.9 NS Normal Saline', 'interventionNames': ['Drug: Placebo (0.9% Normal Saline infusion)']}], 'interventions': [{'name': 'Intravenous Acetaminophen', 'type': 'DRUG', 'otherNames': ['Ofirmev'], 'description': "Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.", 'armGroupLabels': ['Intravenous acetaminophen']}, {'name': 'Placebo (0.9% Normal Saline infusion)', 'type': 'DRUG', 'otherNames': ['NS'], 'description': 'Infusion of 100 ml of 0.9% NS', 'armGroupLabels': ['Placebo (0.9% Normal Saline Infusion)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Celebration Health', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}], 'overallOfficials': [{'name': 'Bradley Homan, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Hospital Celebration Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Central Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}