Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-01 @ 1:29 PM
Study NCT ID:
NCT04625868
Status:
COMPLETED
Last Update Posted:
2021-09-10
First Post:
2020-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2020-07-03', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine milliequivalents consumed in 2 weeks postoperatively', 'timeFrame': '2 weeks after surgery', 'description': 'Total morphine mEq consumed in 2 weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '2 weeks after surgery', 'description': 'Average daily Visual Analog Scaled pain score recorded after surgery. Pain will be recorded on a scale from 0 (no pain) to 10 (worst pain possible).'}, {'measure': 'Patient satisfaction', 'timeFrame': '7-10 days after surgery', 'description': 'Patient satisfaction with pain control after surgery. Satisfaction will be measured on a Likert scale with the following question: "How satisfied have you been with your pain management after surgery?". Answer choices are: Very unsatisfied, unsatisfied, neutral, satisfied, very satisfied.'}, {'measure': 'Proper disposal', 'timeFrame': '2 weeks after surgery', 'description': 'Self-reported proper disposal of unused opioids after surgery. Patients will be asked in a postoperative survey if they used all of the pills in their initial postoperative prescription. If they did not, they will be asked "Have you disposed of your unused opioids via a DEA-approved method (I.e. at a pharmacy or other safe location?)" as a yes or no question.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Hand Injuries and Disorders', 'Surgery']}, 'descriptionModule': {'briefSummary': 'This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.', 'detailedDescription': 'This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery. Patients undergoing elective hand surgery are randomized to either watch a preoperative educational video or not. Patients are asked to record their pain medication usage postoperatively, as well as their daily pain levels and satisfaction with their pain control after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing elective hand surgery\n* surgeon is planning to prescribe opioids for postoperative pain control\n\nExclusion Criteria:\n\n* emergent surgery\n* surgeon not planning to prescribe opioids for postoperative pain control'}, 'identificationModule': {'nctId': 'NCT04625868', 'briefTitle': 'Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery', 'orgStudyIdInfo': {'id': '00211034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soft tissue surgery - preoperative video', 'description': 'Patients \\> 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.', 'interventionNames': ['Other: Educational video']}, {'type': 'NO_INTERVENTION', 'label': 'Soft tissue surgery - no video', 'description': 'Patients \\> 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.'}, {'type': 'EXPERIMENTAL', 'label': 'Bone/joint surgery - preoperative video', 'description': 'Patients \\> 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.', 'interventionNames': ['Other: Educational video']}, {'type': 'NO_INTERVENTION', 'label': 'Bone/joint surgery - no video', 'description': 'Patients \\> 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.'}], 'interventions': [{'name': 'Educational video', 'type': 'OTHER', 'description': 'Patients will watch a preoperative educational video on proper opioid use and disposal.', 'armGroupLabels': ['Bone/joint surgery - preoperative video', 'Soft tissue surgery - preoperative video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'David M. Kalainov, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society for Surgery of the Hand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor of Orthopaedic Surgery', 'investigatorFullName': 'David Kalainov', 'investigatorAffiliation': 'Northwestern University'}}}}