Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-02 @ 7:32 AM
Study NCT ID:
NCT03959969
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2019-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-21', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of oxycodone tablets used fourteen days after cesarean delivery', 'timeFrame': 'A total of 14 days after cesarean delivery (postpartum day number 14)', 'description': 'This is the total number of oxycodone tablets used by participants in each arm fourteen days after cesarean delivery (postpartum day number 14).'}], 'secondaryOutcomes': [{'measure': 'Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery', 'timeFrame': '7 days after cesarean delivery (postpartum day number 7)', 'description': 'Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score seven days after cesarean delivery (postpartum day 7). The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.'}, {'measure': 'Adjunct medication use at seven days after cesarean delivery', 'timeFrame': '7 days after cesarean delivery (postpartum day number 7)', 'description': 'This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, seven days after cesarean delivery.'}, {'measure': 'Overall pain management satisfaction using Likert scale seven days after cesarean delivery', 'timeFrame': '7 days after cesarean delivery (postpartum day number 7)', 'description': 'Assessment of overall pain management satisfaction seven days after cesarean delivery (postpartum day number 7) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.'}, {'measure': 'Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery', 'timeFrame': '14 days after cesarean delivery (postpartum day number 14)', 'description': 'Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score fourteen days after cesarean delivery (postpartum day 14).The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.'}, {'measure': 'Adjunct medication use at fourteen days after cesarean delivery', 'timeFrame': '14 days after cesarean delivery (postpartum day number 14)', 'description': 'This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, fourteen days after cesarean delivery.'}, {'measure': 'Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery', 'timeFrame': '14 days after cesarean delivery (postpartum day number 14)', 'description': 'Assessment of overall pain management satisfaction fourteen days after cesarean delivery (postpartum day number 14) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.'}, {'measure': 'Total number of oxycodone tablets used inpatient', 'timeFrame': '3 days', 'description': "Total oxycodone tablets used during patient's inpatient stay after cesarean delivery."}, {'measure': 'Number of oxycodone tablets used seven days after cesarean delivery', 'timeFrame': '7 days after cesarean delivery (postpartum day number 7)', 'description': 'This is the total number of oxycodone tablets used by participants in each arm seven days after cesarean delivery (postpartum day number 7).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use, Unspecified']}, 'referencesModule': {'references': [{'pmid': '28594762', 'type': 'BACKGROUND', 'citation': 'Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.'}, {'pmid': '28594763', 'type': 'BACKGROUND', 'citation': 'Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.'}, {'pmid': '22345943', 'type': 'BACKGROUND', 'citation': 'Ismail S, Shahzad K, Shafiq F. Observational study to assess the effectiveness of postoperative pain management of patients undergoing elective cesarean section. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):36-40. doi: 10.4103/0970-9185.92432.'}, {'pmid': '29939935', 'type': 'BACKGROUND', 'citation': 'ACOG Committee Opinion No. 742 Summary: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):252-253. doi: 10.1097/AOG.0000000000002711.'}, {'pmid': '34237764', 'type': 'DERIVED', 'citation': 'Mokhtari NB, Saeed H, Kawakita T, Huang JC, Iqbal SN. Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2021 Aug 1;138(2):253-259. doi: 10.1097/AOG.0000000000004468.'}]}, 'descriptionModule': {'briefSummary': "This is a randomized controlled trial assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. The educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video compared to those who received the standard of care discharge instructions without the video. Participants will be contacted 7 and 14 days after cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on their overall pain management and to determine how many opioid tablets have been used."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than 18 years of age\n* Underwent repeat or primary C-section\n* Literate in English Language\n\nExclusion Criteria:\n\n* Complicated cesarean section including cesarean hysterectomy, bowel injury, bladder injury, and/or take-back\n* History of opioid use disorder and/or on chronic opiates in pregnancy\n* Contraindications to NSAIDS or acetaminophen'}, 'identificationModule': {'nctId': 'NCT03959969', 'briefTitle': 'Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery', 'orgStudyIdInfo': {'id': 'STUDY00000260'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Video Recipients', 'description': 'Participants will be shown educational video on pain management after cesarean delivery on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain.', 'interventionNames': ['Other: Educational video', 'Drug: Ibuprofen', 'Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Recipients', 'description': 'Participants will be given standard of care discharge instructions for pain management on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain.', 'interventionNames': ['Other: Standard of care', 'Drug: Ibuprofen', 'Drug: Oxycodone']}], 'interventions': [{'name': 'Educational video', 'type': 'OTHER', 'description': 'An educational video on pain management after cesarean section. The educational video was put together by two general obstetrician-gynecologists, two maternal fetal medicine specialists, and a palliative care physician.', 'armGroupLabels': ['Educational Video Recipients']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.', 'armGroupLabels': ['Standard of Care Recipients']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Advil'], 'description': 'Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.', 'armGroupLabels': ['Educational Video Recipients', 'Standard of Care Recipients']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.', 'armGroupLabels': ['Educational Video Recipients', 'Standard of Care Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Sara Iqbal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maternal Fetal Medicine Fellowship Program Director', 'investigatorFullName': 'Sara N. Iqbal', 'investigatorAffiliation': 'Medstar Health Research Institute'}}}}