Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-16 @ 5:15 PM
Study NCT ID:
NCT07065266
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-15
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Use of a Simplified Pain Questionnaire Impact Opioid Consumption Among People Receiving Anterior Cruciate Ligament (ACL) Knee Surgery?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of opioid medication used post-operatively for 14 days', 'timeFrame': '14 days post-surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament (ACL) Reconstruction', 'Anterior Cruciate Ligament/Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized clinical trial is to compare opioid consumption among patients who receive a binary pain scale compared to those who receive a standard 10-point pain scale after undergoing anterior cruciate ligament (ACL) reconstruction surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+\n* Undergoing ACL reconstruction surgery at Stanford Sports Medicine Redwood City, with autograft or allograft, with or without concomitant meniscal repair.\n\nExclusion Criteria:\n\n* Pregnant women\n* Surgical history of the operated knee\n* Known allergy to opioid medications\n* Received extra-routine pain care (as compared with the average ACL patients at the Sports Medicine division) given by the anesthesiologists, such as the postoperative epidural analgesia or the ultra-sound guided femoral nerve block.'}, 'identificationModule': {'nctId': 'NCT07065266', 'briefTitle': 'Does the Use of a Simplified Pain Questionnaire Impact Opioid Consumption Among People Receiving Anterior Cruciate Ligament (ACL) Knee Surgery?', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Utility of a Dichotomous Pain Scale in Reducing Postoperative Opioids Consumption in Outpatient ACL Surgery: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '45010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10-point pain scale', 'description': 'participants undergoing ACL reconstructive surgery are asked to use a 10-point NPRS pain scale to describe their pain post-operatively', 'interventionNames': ['Other: Numerical Pain Rating Scale (NPRS)']}, {'type': 'EXPERIMENTAL', 'label': 'Binary pain questionnaire', 'description': 'Participants undergoing ACL reconstructive surgery are asked to describe their pain as tolerable or intolerable post-operatively', 'interventionNames': ['Other: Binary pain questionnaire']}], 'interventions': [{'name': 'Binary pain questionnaire', 'type': 'OTHER', 'description': "Post-operative questionnaire that asks if pain is 'tolerable' or 'intolerable'", 'armGroupLabels': ['Binary pain questionnaire']}, {'name': 'Numerical Pain Rating Scale (NPRS)', 'type': 'OTHER', 'description': 'Standard 10-point pain scale used post-operatively to assess pain', 'armGroupLabels': ['10-point pain scale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Orthopaedic and Sports Medicine', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'overallOfficials': [{'name': 'Todd Alamin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopaedic Surgery', 'investigatorFullName': 'Todd Alamin', 'investigatorAffiliation': 'Stanford University'}}}}