Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT06780202
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2025-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018409', 'term': 'Foot Injuries'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D006853', 'term': 'Hydrocodone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003061', 'term': 'Codeine'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Unblinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative Nausea', 'timeFrame': 'Baseline (Day 0), 7 days post op', 'description': 'The subjects will report nausea along the visual analog scale (VAS scale), which they will be educated on before surgery.\n\nA VAS for nausea is a straight line with one end labeled "no nausea" and the other end labeled "worst nausea imaginable". The patient marks a point on the line to indicate their nausea level. The distance from the "no nausea" end of the line is used to score the nausea intensity'}, {'measure': 'Post operative pain', 'timeFrame': 'Baseline, 0.25 months, 1.5 months, 3 months, 6 months', 'description': 'The subject will measure pain along the visual analog scale (VAS scale), which they will be educated on before surgery.\n\nA VAS for pain is a straight line with one end labeled "no pain" and the other end labeled "worst pain imaginable". The patient marks a point on the line to indicate their pain level. The distance from the "no pain" end of the line is used to score the pain intensity'}, {'measure': 'Post operative opioid consumption', 'timeFrame': 'Baseline (Day 0), 7 days post op', 'description': 'Total number of opioids consumed each day will be captured.'}], 'secondaryOutcomes': [{'measure': 'Complications due to the Medrol Dosepak', 'timeFrame': '1.5 months, 3 months, 6 months', 'description': 'Complications will be monitored via radiographs and clinical analyses at post-operative appointments for impaired wound-healing and infection'}, {'measure': 'Patient reported outcomes', 'timeFrame': 'Baseline (pre operative assessment), Post operation (6 months)', 'description': 'Patient-reported outcomes will be measured along the 12-item Short Form Health Survey which measures the impact of their current health on everyday life, the Patient-Reported Outcomes Measurement Information System (PROMIS) which measures physical, mental, and social health and the VAS scale, which measures pain at rest'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VAS scale: visual analog scale', 'Medrol Dosepak'], 'conditions': ['Foot Injuries and Disorders', 'Ankle Injuries and Disorders', 'Achilles Tendon Injury']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries.\n\nThe secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes', 'detailedDescription': 'The opioid epidemic continues to create a lasting impact on society, leading researchers to focus on ways to decrease opioid prescription rates and subsequently, opioid consumption. Opioid-naïve patients undergoing minor to major surgeries have been shown statistically to be largely affected.1 This includes significant numbers resulting from forefoot surgery specifically with around 6.2% of the mentioned population being at risk for new persistent opioid use.\n\nThis has provoked researchers to seek a new route that decreases exposure to opioid use through proposals for multimodal pain regimes.\n\nA recent addition to some of these proposed treatments has been a 6-day low-dose oral methylprednisolone taper beginning on the day of surgery. This has been tested with "terrible triad" elbow injuries, distal radius fractures, and total shoulder arthroplasties with promising results showing decreased consumption of the as-needed opioid prescription. Furthermore, the results of these studies show a significant decrease in pain and increased range of motion following surgery. This is likely due to the anti-inflammatory functioning of glucocorticoids, without inhibiting the healing process.\n\nBased upon the findings stated above, the proposed research will attempt to apply this new pain regime to foot and ankle surgeries, specifically forefoot, ankle, and Achilles surgeries, to take another step towards bettering perioperative care with opioid-free treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Emory Orthopedic patients undergoing foot and ankle surgery\n\nExclusion Criteria:\n\n* Concurrent or significant injuries to other bones or organs\n* Local infections\n* History of alcohol or medical abuse, including prior opioid abuse\n* Smoking\n* History of severe heart disease, renal failure, liver dysfunction, active peptic ulcer disease, diabetes, rheumatoid arthritis, neurological or psychiatric diseases that could influence pain perception\n* Pre-existing immune suppression\n* Those deemed possibly non-compliant by the study team and,\n* All vulnerable populations (those unable to give consent, juveniles, pregnant women, prisoners, cognitively impaired and non-English speaking).'}, 'identificationModule': {'nctId': 'NCT06780202', 'briefTitle': 'Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients', 'orgStudyIdInfo': {'id': 'STUDY00008454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medrol', 'description': 'The group will be given Medrol Dosepak in a tapered, low-dose manner, orally once a day.\n\nSubjects will be sent home with a pain journal where they will record their pain and nausea 3 times daily starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. These journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. In this appointment, subjects will also be evaluated for complications.', 'interventionNames': ['Drug: medrol dosepak', 'Drug: HYDROcodone Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Each subject will receive the standard pain regime of both surgeons. This includes a nerve block before surgery for pain prevention. While in surgery, the subject will receive 10 mg of dexamethasone intravenously. Post-surgery, each subject will be instructed to take vitamin C for nerve pain and vitamin D for bone healing. They will also be provided with a prescription of aspirin for deep vein thrombosis (DVT) prophylaxis, ondansetron (Zofran) for nausea, and Colace for constipation relief. Both groups will receive a prescription of 20 5 mg hydrocodone pills to be taken as needed for pain, 1 every 6 hours\n\nSubjects will be sent home with a pain journal where they will record their pain and nausea 3 times starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. Journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. Subjects will also be evaluated for complications', 'interventionNames': ['Drug: HYDROcodone Oral Tablet']}], 'interventions': [{'name': 'medrol dosepak', 'type': 'DRUG', 'otherNames': ['Methylprednisolone'], 'description': 'Methylprednisolone is a corticosteroid with anti-inflammatory properties and immune suppression.\n\nThis study will utilize a 6-day Medrol Dosepak: a tapered low-dose corticosteroid course taken orally once a day. This includes 6 tablets on day 1 (24 mg), 5 tablets on day 2 (20 mg), 4 tablets on day 3 (16 mg), 3 tablets on day 4 (12 mg), 2 tablets on day 5 (8 mg) and 1 tablet on day 6 (4 mg).', 'armGroupLabels': ['Medrol']}, {'name': 'HYDROcodone Oral Tablet', 'type': 'DRUG', 'description': 'This study will utilize a prescription of 20 pills of hydrocodone, 5mg each, to be taken as needed for pain, 1 every 6 hours.', 'armGroupLabels': ['Medrol', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Bariteau, MD', 'role': 'CONTACT', 'email': 'jason.bariteau@emory.edu', 'phone': '404-778-3350'}, {'name': 'Jason Kadakia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rishin Bariteau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30022', 'city': 'Johns Creek', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rishin Kadakia, MD', 'role': 'CONTACT', 'email': 'rishin.j.kadakia@emory.edu', 'phone': '404-778-3350'}], 'facility': 'Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center', 'geoPoint': {'lat': 34.02893, 'lon': -84.19858}}], 'centralContacts': [{'name': 'Jason Bariteau, MD', 'role': 'CONTACT', 'email': 'jason.bariteau@emory.edu', 'phone': '404-778-3350'}], 'overallOfficials': [{'name': 'Rishin Kadakia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jason Bariteau', 'investigatorAffiliation': 'Emory University'}}}}