Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-26 @ 8:53 PM
Study NCT ID:
NCT04469868
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2020-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
No Opioids PrescrIptions On Discharge After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients who undergo major urologic oncology surgery will be eligible to be enrolled.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioids prescribing at hospital discharge', 'timeFrame': '30 days', 'description': 'Patients will be discharged with no or few opioids after surgery along with instruction on how to use non-opioid analgesic measures.'}, {'measure': 'All opioids prescriptions within 30 days of surgery', 'timeFrame': '30 days', 'description': 'The electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider'}], 'secondaryOutcomes': [{'measure': 'Post-operative pain after discharge', 'timeFrame': '7 days', 'description': 'Visual analog pain scale (which ranges from 0-10) will be completed daily for 7 days. Score of zero signifies no pain at all and a a score of 10 implies the worst pain ever experienced.'}, {'measure': 'Satisfaction score during home recovery', 'timeFrame': '7 days', 'description': 'Overall satisfaction score (0-100%) with post-operative pain, discomfort and recovery at home. A higher score signifies more satisfaction with pain control during the recovery process.'}, {'measure': 'Contact with healthcare facilities', 'timeFrame': '30 days', 'description': 'All phone calls to the clinic, unplanned visits, emergency room visits, hospital admissions will recorded and combined as a single measure of contact with any healthcare facility as a measure of resource utilization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioids', 'Prescriptions', 'Surgery', 'Recovery', 'Pain score'], 'conditions': ['Opioid Use', 'Prescription Drug Abuse and Dependency', 'Surgery', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Opioid analgesics are routinely prescribed for these patients for post-operative pain control. Even a short exposure to opioids in opioid-naïve patients following minor or major surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of patients. The goal of the study to eliminate the use of outpatient opioids prescriptions after major urologic surgery.', 'detailedDescription': 'Nearly 200 million opioid prescriptions are dispensed per year in the United States. Opioid prescriptions given by medical providers are a major contributor to the opioid abuse epidemic. Nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. Among patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to their abuse diagnosis and 51% had a family member who had an opioid prescription, Thus, opioids prescriptions, which are often in excess of the need by the patient, are a major contributor to this public health crisis.\n\nThe investigators devised a prospective intervention study to eliminate or significantly reduced the use of opioids prescribed at hospital discharge after major urologic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing major urologic cancer surgery, either open or laparoscopic, will be included in the study.\n* This will include all open or laparoscopic or robotic surgery including radical prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy, nephron-ureterectomy, and similar procedures.\n\nExclusion Criteria:\n\n* Those with allergy or intolerance to NSAIDS may be excluded.'}, 'identificationModule': {'nctId': 'NCT04469868', 'acronym': 'NOPIOiDS', 'briefTitle': 'No Opioids PrescrIptions On Discharge After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Prospective Study of No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)', 'orgStudyIdInfo': {'id': '5866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No opioids prescriptions at discharge', 'description': 'Patients will receive non-opioid analgesia, mostly over the counter, medications such as acetaminophen or ibuprofen. Opioids may be prescribed if the patients experience break through pain and call the office.', 'interventionNames': ['Behavioral: No opioids at discharge']}], 'interventions': [{'name': 'No opioids at discharge', 'type': 'BEHAVIORAL', 'description': 'Patients who are being scheduled for any major urologic cancer surgery (open or laparoscopic) will be counselled regarding post-operative pain and measures taken during surgery and during hospital stay.\n\nThey will be provided written information on these pain mitigation efforts and the adverse effects associated with opioids use and outpatient prescriptions.\n\nPatients will be discharged from the hospital without any opioids prescriptions and instructions to use non-opioids analgesics.\n\nPatients will complete a visual analog pain scale daily for 7 days after discharge from the hospital.\n\nPatients will be able to call the clinic at anytime for any post-operative pain issues.', 'armGroupLabels': ['No opioids prescriptions at discharge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Badar Mian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Badar M. Mian', 'investigatorAffiliation': 'Albany Medical College'}}}}