Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-28 @ 4:20 AM
Study NCT ID:
NCT05285566
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Control for Undergoing Costal Cartilage Harvesting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': '7-10 days following the last administration of study treatment', 'description': 'Measured using a visual analog scale 0=no pain and 10=worst possible'}, {'measure': 'Change in oral pain medication', 'timeFrame': '7-10 days following the last administration of study treatment', 'description': 'Total oral pain medication usage self-reported in pain medication diary'}], 'secondaryOutcomes': [{'measure': 'Adverse Reactions', 'timeFrame': '7-10 days following the last administration of study treatment', 'description': 'Total number of adverse reactions reported to the study agent'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasal Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether injecting the U.S. Food and Drug Administration (FDA) approved drug EXPAREL®, a long acting (approximately 96 hours) numbing medication, will reduce pain after rib cartilage removal in comparison to the standard injection of XYLOCAINE®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of functional nasal obstruction or aesthetic nasal concern requiring nasal surgery with costal cartilage harvest.\n* Willing and able to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Known pregnancy.\n* Women who are currently nursing a child.\n* History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder.\n* Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation.\n* Inability to provide informed consent (patients under guardianship).\n* Known hypersensitivity to local anesthetics\n* History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.\n* History of complex pulmonary disease; such as uncontrolled asthma, COPD, or interstitial lung disease as determined by history or review of the medical record.\n\nImpaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate \\< 60 mL/min/BSA as determined by history or review of the medical record.\n\n\\- History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.'}, 'identificationModule': {'nctId': 'NCT05285566', 'briefTitle': 'Pain Control for Undergoing Costal Cartilage Harvesting', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest', 'orgStudyIdInfo': {'id': '21-008473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exparel® Injection Group', 'description': 'On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Exparel®', 'interventionNames': ['Drug: Exparel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xylocaine® Injection Group', 'description': 'On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Xylocaine® as part of standard of care.', 'interventionNames': ['Drug: Xylocaine']}], 'interventions': [{'name': 'Exparel', 'type': 'DRUG', 'otherNames': ['Liposomal bupivacaine'], 'description': '106mg (8 mL) subcutaneous injection injected after costal cartilage harvest', 'armGroupLabels': ['Exparel® Injection Group']}, {'name': 'Xylocaine', 'type': 'DRUG', 'otherNames': ['Lidocaine'], 'description': '8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site', 'armGroupLabels': ['Xylocaine® Injection Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dan Osland', 'role': 'CONTACT', 'email': 'osland.daniel@mayo.edu'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Amy Tuchscherer', 'role': 'CONTACT', 'email': 'Tuchscherer.Amy@mayo.edu', 'phone': '507-538-6582'}], 'overallOfficials': [{'name': 'Michael D Olson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael D. Olson, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}