Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-12 @ 5:03 AM
Study NCT ID:
NCT03299920
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2017-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Consumption After Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-09-28', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of opioid medication doses taken', 'timeFrame': 'Post-op day 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Procedure, Unspecified', 'Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy surgery and receiving a peripheral nerve block. Patients will be randomized to either receive standard discharge teaching or specialized teaching regarding pain control following a nerve block. Patients will be asked to complete a journal for 5 days recording their pain scores, opioid medication usage, and overall satisfaction with pain control at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy\n* American Society of Anesthesiology physical status I or II\n\nExclusion Criteria:\n\n* Anterior cruciate ligament repair or reconstruction\n* Admission to hospital\n* Inability or refusal to receive femoral nerve blockade\n* Body mass index \\> 99 percentile\n* Hydrocodone allergy or intolerance\n* Acetaminophen allergy or intolerance\n* Non-steroidal anti-inflammatory allergy or intolerance\n* Pregnancy\n* Interpreter requirement\n* Opioid use within 3 months prior to surgery\n* Previous knee surgery at WSC after Jan. 1, 2017\n* History of opioid abuse or dependence'}, 'identificationModule': {'nctId': 'NCT03299920', 'briefTitle': 'Opioid Consumption After Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Opioid Consumption After Knee Arthroscopy With and Without the Use of New Standardized Patient/Family Instructions for Postoperative Analgesic Use', 'orgStudyIdInfo': {'id': 'IRB17-00710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics.', 'interventionNames': ['Other: Standardized instructions']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Patient will receive conventional instructions on postoperative pain management.', 'interventionNames': ['Other: Conventional instructions']}], 'interventions': [{'name': 'Standardized instructions', 'type': 'OTHER', 'description': 'Specific instructions related to peripheral nerve block.', 'armGroupLabels': ['Intervention']}, {'name': 'Conventional instructions', 'type': 'OTHER', 'description': 'Usual post-operative instructions.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Giorgio Veneziano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giorgio Veneziano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Regional Anesthesia Service', 'investigatorFullName': 'Giorgio Veneziano', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}