Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT02449369
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D009966', 'term': 'Orphenadrine'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'D004091', 'term': 'Hydromorphone'}, {'id': 'D010098', 'term': 'Oxycodone'}], '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'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'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': 'D003061', 'term': 'Codeine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-29', 'studyFirstSubmitDate': '2015-05-14', 'studyFirstSubmitQcDate': '2015-05-16', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Routine Pain Intensity Scores', 'timeFrame': '48 hours', 'description': 'verbal subjective assessment by patient reported to nursing at standard assessment times as an ordinal number between 0 and 10 (inclusive) where 0 is no pain and 10 is the maximum pain imaginable'}, {'measure': 'Abbreviated Pain Intensity Scores', 'timeFrame': '48 hours', 'description': 'Verbal subjective assessment by patient reported to nursing at standard assessment times as either "mild", "moderate", or "severe".'}, {'measure': 'Opioid Consumption,', 'timeFrame': '48 hours', 'description': 'recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.'}, {'measure': 'Physical therapy metrics/goals', 'timeFrame': '48 hours', 'description': 'measured and recorded by physical therapist in daily chart notes quantifying ability to get out of bed, range of motion (in flexion/extension degrees) and average and maximum ambulation (in feet) during postoperative days 0 to 2.'}], 'secondaryOutcomes': [{'measure': 'PACU discharge', 'timeFrame': '48 hours', 'description': 'Time to discharge from the PACU will be measured from PACU arrival to time of PACU discharge criteria met in minutes.'}, {'measure': 'Hospital Discharge', 'timeFrame': '48 hours', 'description': 'Time to discharge from the hospital will be measured from time/date of surgical incision to time/date that hospital discharge criteria is met, measured in hours.'}, {'measure': 'Patient satisfaction', 'timeFrame': '48 hours', 'description': '19 point validated questionnaire of perioperative satisfaction with items for regional anesthesia'}, {'measure': 'Cost as measured by', 'timeFrame': '48 hours', 'description': 'study medication acquisition cost reported by pharmacy, study medication administration cost reported by pharmacy and nursing, length of stay cost reported by hospital accounting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unilateral Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '23379573', 'type': 'RESULT', 'citation': 'Looke TD, Kluth CT. Effect of preoperative intravenous methocarbamol and intravenous acetaminophen on opioid use after primary total hip and knee replacement. Orthopedics. 2013 Feb;36(2 Suppl):25-32. doi: 10.3928/01477447-20130122-54.'}, {'pmid': '19338859', 'type': 'RESULT', 'citation': 'Hidalgo DA, Pusic AL. The role of methocarbamol and intercostal nerve blocks for pain management in breast augmentation. Aesthet Surg J. 2005 Nov-Dec;25(6):571-5. doi: 10.1016/j.asj.2005.09.003.'}, {'pmid': '19331993', 'type': 'RESULT', 'citation': 'Schneider MS. Methocarbamol: adjunct therapy for pain management in breast augmentation. Aesthet Surg J. 2002 Jul;22(4):380-1. doi: 10.1067/maj.2002.126750.'}, {'pmid': '9204163', 'type': 'RESULT', 'citation': 'Schneider MS. Pain reduction in breast augmentation using methocarbamol. Aesthetic Plast Surg. 1997 Jan-Feb;21(1):23-4. doi: 10.1007/s002669900076.'}, {'pmid': '20890791', 'type': 'RESULT', 'citation': 'Gombotz H, Lochner R, Sigl R, Blasl J, Herzer G, Trimmel H. Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. Wien Med Wochenschr. 2010 Nov;160(19-20):526-34. doi: 10.1007/s10354-010-0829-7. Epub 2010 Oct 8.'}, {'pmid': '15151094', 'type': 'RESULT', 'citation': 'Malek J, Nedelova I, Lopourova M, Stefan M, Kostal R. [Diclofenac 75mg. and 30 mg. orfenadine (Neodolpasse) versus placebo and piroxicam in postoperative analgesia after arthroscopy]. Acta Chir Orthop Traumatol Cech. 2004;71(2):80-3. Czech.'}, {'pmid': '22008309', 'type': 'RESULT', 'citation': 'Sinatra RS, Jahr JS, Reynolds L, Groudine SB, Royal MA, Breitmeyer JB, Viscusi ER. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012 Jun;12(5):357-65. doi: 10.1111/j.1533-2500.2011.00514.x. Epub 2011 Oct 19.'}, {'pmid': '15791113', 'type': 'RESULT', 'citation': 'Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.'}, {'pmid': '20173643', 'type': 'RESULT', 'citation': 'Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.'}, {'pmid': '22524979', 'type': 'RESULT', 'citation': 'Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.'}, {'pmid': '23221859', 'type': 'RESULT', 'citation': 'Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.', 'detailedDescription': 'This research will be a prospective, three-arm, randomized, open-label trial to assess opioid use and patient reported outcomes after 48 hours of regular IV acetaminophen and muscle relaxant (IVAM) orphenadrine administration following total knee replacement surgery. 180 patients (60 in each arm) will be randomized to receive the standard group treatment, the IVAM group treatment, or to the control grouptreatment.\n\nStandard Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours) as requested by the surgeon; preoperative (single dose) intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative oral oxycodone (5 mg) with acetaminophen (325 mg) (PRN dosing), oral orphenadrine (100 mg) every 12 hours for 3 doses, and intravenous hydromorphone (PRN dosing) for breakthrough pain.\n\nControl Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative (single dose) intravenous acetaminophen (1000 mg) intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; and postoperative oral oxycodone and acetaminophen (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.\n\nIVAM Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative intravenous acetaminophen (1000 mg) every 6 hours routine for total of 8 doses and intravenous orphenadrine (60 mg) every 12 hours for total of 4 doses; oral oxycodone (5 mg) (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-85\n2. Primary, unilateral total knee arthroplasty\n3. American Society of Anesthesiologist (ASA) physical status I, II, or III\n\nExclusion Criteria:\n\n1. Chronic pain (as determined by regular opioid use in the month preceding surgery)\n2. Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery\n3. Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)\n4. Severe renal dysfunction, creatinine \\> 2.0\n5. Allergy or other contraindications to use of orphenadrine and/or acetaminophen\n6. Pregnant or breast feeding\n7. Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.\n8. History of Hepatitis, B or C,\n9. History of cirrhosis or hepatic insufficiency'}, 'identificationModule': {'nctId': 'NCT02449369', 'acronym': 'IVAM', 'briefTitle': 'Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes.', 'orgStudyIdInfo': {'id': '521770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Preop acetaminophen IV 1000 mg, Postop oral oxycodone \\& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, and Postop hydromorphone IV 0.5 mg every 4 hours PRN', 'interventionNames': ['Drug: Preop acetaminophen IV', 'Drug: Postop oral oxycodone & acetaminophen', 'Drug: Postop hydromorphone IV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop oral orphenadrine 100 mg every 12 hours for 3 doses, Postop oral oxycodone \\& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN', 'interventionNames': ['Drug: Preop acetaminophen IV', 'Drug: Preop orphenadrine IV', 'Drug: Postop oral oxycodone & acetaminophen', 'Drug: Postop hydromorphone IV', 'Drug: Postop oral orphenadrine']}, {'type': 'EXPERIMENTAL', 'label': 'IVAM', 'description': 'Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop acetaminophen IV 1000 mg every 6 hours for 7 doses, Postop orphenadrine IV 60 mg every 12 hours for 3 doses, Postop oral oxycodone 5 mg 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN', 'interventionNames': ['Drug: Preop acetaminophen IV', 'Drug: Preop orphenadrine IV', 'Drug: Postop hydromorphone IV', 'Drug: Postop oral oxycodone', 'Drug: Postop acetaminophen IV', 'Drug: Postop orphenadrine IV']}], 'interventions': [{'name': 'Preop acetaminophen IV', 'type': 'DRUG', 'otherNames': ['Ofirmev'], 'armGroupLabels': ['Control', 'IVAM', 'Standard']}, {'name': 'Preop orphenadrine IV', 'type': 'DRUG', 'otherNames': ['Norflex'], 'armGroupLabels': ['IVAM', 'Standard']}, {'name': 'Postop oral oxycodone & acetaminophen', 'type': 'DRUG', 'otherNames': ['Percocet'], 'armGroupLabels': ['Control', 'Standard']}, {'name': 'Postop hydromorphone IV', 'type': 'DRUG', 'otherNames': ['Dilaudid'], 'armGroupLabels': ['Control', 'IVAM', 'Standard']}, {'name': 'Postop oral orphenadrine', 'type': 'DRUG', 'otherNames': ['Norflex'], 'armGroupLabels': ['Standard']}, {'name': 'Postop oral oxycodone', 'type': 'DRUG', 'otherNames': ['Roxicodone'], 'armGroupLabels': ['IVAM']}, {'name': 'Postop acetaminophen IV', 'type': 'DRUG', 'otherNames': ['Ofirmev'], 'armGroupLabels': ['IVAM']}, {'name': 'Postop orphenadrine IV', 'type': 'DRUG', 'otherNames': ['Norflex'], 'armGroupLabels': ['IVAM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Winter Park', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}], 'overallOfficials': [{'name': 'thomas Looke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sagent Pharmaceuticals Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}