Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT04102566
Status:
RECRUITING
Last Update Posted:
2019-09-27
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Pain Control in Transurethral Resection of the Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-05', 'mcpReleaseN': 2, 'releaseDate': '2023-04-12'}], 'estimatedResultsFirstSubmitDate': '2023-04-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': 'PACU-72 hours', 'description': 'Total opioid utilization'}, {'measure': 'Pain Scores', 'timeFrame': 'PACU-72 hours', 'description': 'Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)'}], 'secondaryOutcomes': [{'measure': 'Presence of a foley catheter at discharge.', 'timeFrame': '0-48hours', 'description': 'Was the patient discharged with a Foley catheter?'}, {'measure': 'Presence of narcotic side effects', 'timeFrame': '48 hours after discharge', 'description': 'nausea/vomiting, pruritus, constipation, dizziness or feelings of sedation'}, {'measure': 'Were there any post-operative complications', 'timeFrame': '0-48 hours', 'description': 'Any complications post-operatively that occurred in the immediate post-operative setting.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'Transurethral resection of the prostate', 'Multimodal pain control'], 'conditions': ['Pain', 'BPH With Urinary Obstruction', 'BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '22412106', 'type': 'BACKGROUND', 'citation': 'Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.'}, {'pmid': '27400458', 'type': 'BACKGROUND', 'citation': 'Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.'}, {'pmid': '28267689', 'type': 'BACKGROUND', 'citation': 'Hill MV, Stucke RS, McMahon ML, Beeman JL, Barth RJ Jr. An Educational Intervention Decreases Opioid Prescribing After General Surgical Operations. Ann Surg. 2018 Mar;267(3):468-472. doi: 10.1097/SLA.0000000000002198.'}, {'pmid': '27631771', 'type': 'BACKGROUND', 'citation': 'Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.'}, {'pmid': '23565930', 'type': 'BACKGROUND', 'citation': 'Kose O, Saglam HS, Altun ME, Sonbahar T, Kumsar S, Adsan O. Prilocaine irrigation for pain relief after transurethral resection of the prostate. J Endourol. 2013 Jul;27(7):892-5. doi: 10.1089/end.2013.0001. Epub 2013 Jun 12.'}, {'pmid': '22227789', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.'}, {'pmid': '26977696', 'type': 'BACKGROUND', 'citation': 'Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.'}, {'pmid': '27663358', 'type': 'BACKGROUND', 'citation': 'Maughan BC, Hersh EV, Shofer FS, Wanner KJ, Archer E, Carrasco LR, Rhodes KV. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend. 2016 Nov 1;168:328-334. doi: 10.1016/j.drugalcdep.2016.08.016. Epub 2016 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.', 'detailedDescription': 'In our study, the investigators will randomize TURP patients to standard of care versus a multi-modal protocol. Multi-modal pain control is defined as: "analgesia that combines 2 or more agents that act by different mechanisms to provide analgesia with better pain relief and less opioids". In addition, patients in the intervention arm will receive education regarding pain control and opioid use. The investigators aim to demonstrate non-inferior pain control with this approach. The investigators hope this will inform new guidelines for pain control after TURP, minimize opioid use in this patient population, and educate physicians and patients on providing excellent pain control while minimizing the risks of opioid use. The investigators believe this could ultimately serve as a model for other endoscopic urologic procedures as well.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are identified as candidates for TURP\n* Are 18 years of age or greater\n* Are proficient in English\n\nExclusion Criteria:\n\n* Have filled an opioid prescription in the last 2 months\n* Have an allergy to a medication included in the protocol\n* Have a history of pelvic radiation\n* Have renal failure (Serum Cr \\> 2.0 mg/dl), peptic ulcer disease, history of gastric bypass, cirrhosis, or other contraindication precluding use of NSAID's\n* Have liver failure, hepatitis, or alcohol abuse which precludes use of acetaminophen"}, 'identificationModule': {'nctId': 'NCT04102566', 'briefTitle': 'Optimizing Pain Control in Transurethral Resection of the Prostate', 'organization': {'class': 'OTHER', 'fullName': 'Benaroya Research Institute'}, 'officialTitle': 'Optimizing Pain Control in Transurethral Resection of the Prostate', 'orgStudyIdInfo': {'id': 'IRB17-098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care arm', 'description': 'The standard of care group will group will receive the following regimen while inpatient:\n\n* 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours\n* Acetaminophen 1000mg every 8 hours standing\n* Oxycodone 5mg PO every 4 hours as needed pain\n* Phenazopyridine 100mg TID as needed for urinary burning\n* Senna 1 tab every 12 hours\n* Miralax 17g powder once daily as needed for constipation\n\nThe standard of care group will get the following prescriptions on discharge:\n\n* Oxycodone 5mg every 4 hours as needed pain - 15 tabs\n* Acetaminophen 1000mg every 8 hours standing for two days then as needed\n* Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs\n* Senna 1 tab every 12 hours - 10 tabs'}, {'type': 'EXPERIMENTAL', 'label': 'Multi-modal group', 'description': 'The multi-modal group will receive the following regimen while inpatient:\n\n* 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours\n* Acetaminophen 1000mg every 8 hours standing\n* Ibuprofen 600mg every 6 hours standing\n* Oxycodone 5mg PO every 4 hours as needed pain\n* Phenazopyridine 100mg TID as needed for urinary burning\n* Senna 1 tab every 12 hours\n* Miralax 17g powder once daily as needed for constipation\n* Patient Education (Figures 2 \\& 3)\n\nThe multi-modal group will receive the following prescriptions on discharge:\n\n* Acetaminophen 1000mg every 8 hours standing for two days then as needed - 30 tabs\n* Ibuprofen 600mg every 8 hours standing for two days then as needed - 30 tabs\n* Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs\n* Senna 1 tab every 12 hours - 10 tabs', 'interventionNames': ['Drug: Ibuprofen 600 mg', 'Behavioral: Education']}], 'interventions': [{'name': 'Ibuprofen 600 mg', 'type': 'DRUG', 'description': "We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.", 'armGroupLabels': ['Multi-modal group']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': "We'll be adding education to patient's post-operative instructions to aid in their pain control management.", 'armGroupLabels': ['Multi-modal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ryan Donahue, MD', 'role': 'CONTACT', 'email': 'ryan.donahue@vmmc.org', 'phone': '512-484-3214'}, {'name': 'Una Lee, MD', 'role': 'CONTACT', 'email': 'una.lee@vmmc.org', 'phone': '2062236749'}, {'name': 'Kathleen Kobashi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alvaro Lucioni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fred Govier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher Porter, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'John Corman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Pritchett, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher Kuhr, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dena Moskowitz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Neil Hanson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrew Stamm, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ryan Donahue, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Una Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Ryan Donahue, MD', 'role': 'CONTACT', 'email': 'ryan.donahue@vmmc.org', 'phone': '2062236600'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers. IPD will be used solely for this study cohort and protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benaroya Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Virginia Mason Hospital/Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator and Attending urologist', 'investigatorFullName': 'Una Lee', 'investigatorAffiliation': 'Benaroya Research Institute'}}}}