Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-05 @ 6:00 PM
Study NCT ID:
NCT05442268
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-16', 'studyFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2022-06-28', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '48 hours postoperatively', 'description': 'Postoperative Total morphine consumption will be recorded'}], 'secondaryOutcomes': [{'measure': 'First analgesic request', 'timeFrame': '24 hours postoperatively', 'description': 'First analgesic request will be recorded'}, {'measure': 'Post-operative pain', 'timeFrame': '48 hours postoperatively.', 'description': 'Post-operative pain will be assessed by visual analogue score (VAS) from 0-10 scale 0 (no pain) to 10 (the worst imaginable pain) at 2,4,6 h then every 6h'}, {'measure': 'Heart rate', 'timeFrame': '48 hours postoperatively', 'description': 'Heart rate will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively'}, {'measure': 'Mean arterial blood pressure', 'timeFrame': '48 hours postoperatively', 'description': 'Mean arterial blood pressure will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively'}, {'measure': 'Adverse effects', 'timeFrame': '48 hours postoperatively', 'description': 'Hypotension, Bradycardia, nausea, dry mouth,diarrhea, constipation,insomnia, somnolence, fatigue, hyperhidrosis and pruritus will be observed and treated accordingly'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Modified Radical Mastectomy', 'Postoperative Analgesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy.', 'detailedDescription': 'Inadequate control of postoperative pain is associated with increased length of hospital stay, increased hospital cost, sleep disturbance, depression, functional impairment and affects the quality of life.\n\nModified is one of the commonly performed procedures which is associated with severe postoperative pain.\n\nPreemptive analgesia is the analgesic treatment initiated before the surgical procedure to prevent central sensitization from the noxious stimuli. Drugs such as gabapentin, pregabalin, serotonin-norepinephrine reuptake inhibitors, dexamethasone, and cyclooxygenase-2 inhibitors have been used for preemptive analgesia.\n\nThere are contrary results about the role of duloxetine in mangement of acute postoperative pain.\n\nArecent meta-analysis was done in 2020 that concluded that the currently available evidence does not support the clinical use of duloxetine for the management of acute postoperative pain,so we will discuss that in this study.\n\nThere are many studies that have shown that perioperative use of duloxetine for a few days has a significant effect on reducing postoperative pain and analgesic requirements.\n\nDuloxetine is a dual anti-depressant drug that inhibits the neuronal reuptake of serotonin (5-HT) and norepinephrine (NE) modulating the descending inhibitory pain pathways by increasing the availability of serotonin and norepinephrine. Duloxetine is an approved drug for the treatment of post-traumatic depression, major depression, and generalized anxiety disorder. It is also approved for the treatment of various chronic painful syndromes, including neuropathic pain associated with diabetes, chronic musculoskeletal pain, and fibromyalgia.\n\nThe mechanisms of action so far described suggest that duloxetine may be useful as an adjunct in the treatment of acute postoperative pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III\n\nExclusion Criteria:\n\nKnown Allergies to duloxetine.\n\n* Abnormal liver or renal function tests.\n* Narrow angle glaucoma.\n* Being a chronic opioid abuser (more than 3 months)\n* Being on chronic gabapentin or pregabalin (more than 3 months)\n* Being on Monoamine oxidase inhibitor, tricyclic antidepressant, or fluvoxamine.\n* Pregnant female\n* Patients with psychiatric disorders or seizure disorders.'}, 'identificationModule': {'nctId': 'NCT05442268', 'briefTitle': 'Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '35146/12/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetaminophen group', 'description': 'patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively.', 'interventionNames': ['Procedure: Acetaminophen group']}, {'type': 'EXPERIMENTAL', 'label': 'Duloxetine group', 'description': 'Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen (every 6 hours postoperatively)', 'interventionNames': ['Procedure: Duloxetine group']}], 'interventions': [{'name': 'Acetaminophen group', 'type': 'PROCEDURE', 'description': 'patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively', 'armGroupLabels': ['Acetaminophen group']}, {'name': 'Duloxetine group', 'type': 'PROCEDURE', 'description': 'Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen every 6 hours postoperatively', 'armGroupLabels': ['Duloxetine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Elgarbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dina Elfeky, M.B.B.CH', 'role': 'CONTACT', 'email': 'dena154452@med.tanta.edu.eg', 'phoneExt': '+20'}], 'facility': 'Tanta University hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Dina Elfeky, M.B.B.CH.', 'role': 'CONTACT', 'email': 'dena154452@med.tanta.edu.eg', 'phone': '0 111 747 2680', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'one year after the end of the study', 'ipdSharing': 'YES', 'description': 'Data will be available under a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dina Abdel monem Elfeky', 'investigatorAffiliation': 'Tanta University'}}}}