Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-29 @ 2:54 PM
Study NCT ID:
NCT06807866
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Milligram Morphine Equivalent (MME)', 'timeFrame': 'Up to 24 hours', 'description': 'The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief'}], 'secondaryOutcomes': [{'measure': 'Change in Pain as measured by Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, up to 24 hours, 3 months', 'description': 'The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.'}, {'measure': 'Musculoskeletal function as measured by SMFA questionnaire', 'timeFrame': 'Up to 3 months', 'description': "The Short Musculoskeletal Function Assessment Questionnaire (SMFA) consists of 34 questions covering the assessment of the patients function and 12 questions related to how bothered patients are by their symptoms. All categories are scored together, totaling between 0-100 percent. The lower the score, the better the subject's function"}, {'measure': 'Hospital Length of stay measured in hours', 'timeFrame': 'Up to 96 hours', 'description': 'Hospital Length of stay measured in hours'}, {'measure': 'Ambulation distance measured by meters', 'timeFrame': 'Up to 3 months', 'description': 'Ambulation distance measured by meters'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['THA']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years of age\n* Patients undergoing primary total hip arthroplasty\n* Ambulatory patient prior to fracture\n* Subjects must be capable of providing informed consent\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Previous hemiarthroplasty or THA on ipsilateral hip\n* History of Complex Regional Pain Syndrome in ipsilateral extremity\n* History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation\n* Acute or chronic hip infection in ipsilateral extremity\n* Pregnant or breastfeeding\n* Open fracture\n* Polytrauma\n* Intravenous or drug users within 6 months of surgery\n* Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40\n* Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant\n* Severe renal dysfunctions, such as glomerular filtration rate less than 30\n* Moderate to severe depression as diagnosed by a clinician\n* Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives\n* History of uncontrolled narrow angle glaucoma'}, 'identificationModule': {'nctId': 'NCT06807866', 'briefTitle': 'Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)', 'orgStudyIdInfo': {'id': '20240579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine group', 'description': 'Participants will be in this group for up to 2 hours.', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Participants will be in this group for up to 2 hours.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'description': 'Participants will come in person and receive a one time 60 mg dose by mouth.', 'armGroupLabels': ['Duloxetine group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalia Cruz, MD', 'role': 'CONTACT', 'email': 'nxc971@miami.edu', 'phone': '305-689-5195'}, {'name': 'Ryan Hellinger, BA', 'role': 'CONTACT', 'email': 'rlh147@miami.edu', 'phone': '3056895195'}, {'name': 'Victor H Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Natalia Cruz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ryan Hellinger, BA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Victor Hernandez, MD', 'role': 'CONTACT', 'email': 'vhh1@miami.edu', 'phone': '3056895195'}, {'name': 'Natalia Cruz, MD', 'role': 'CONTACT', 'email': 'nxc971@miami.edu', 'phone': '3056895195'}], 'overallOfficials': [{'name': 'Victor Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Victor Hugo Hernandez', 'investigatorAffiliation': 'University of Miami'}}}}