Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT03350334
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants do not know whether they take placebo or Duloxetine'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomised'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2017-11-13', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery-40 questionnaire total score', 'timeFrame': '24 hours after surgery', 'description': 'Total scores of the Quality of Recovery-40 scale will be obtained 24 hours after surgery. Quality of Recovery-40 scale is a validated post-operative recovery questionnaire that consists of 40 questions, and 5 sub-components for pain (7), physical comfort (12), physical independence (5), emotional state (9), and psychological support (7). Positive items are scored from 1 (worst) to 5 (best); scores are reversed for negative items. Each item is scored ranging from 1 to 5. Total questionnaire score is calculated by sum of all items, and also sub-components by the sum of corresponding items. The total score ranges from 40 to 200.'}], 'secondaryOutcomes': [{'measure': 'Narcotic analgesic consumption doses', 'timeFrame': '24 hours after surgery', 'description': 'Number of total narcotic analgesic consumption doses of the participants through the post-operative 24 hours.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'post-operative 1 week', 'description': 'number of days participants stay in hospital'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Duloxetine', 'laparoscopic hysterectomy', 'postoperative pain', 'postoperative recovery'], 'conditions': ['Laparoscopic Hysterectomy', 'Postoperative Recovery', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '26421810', 'type': 'RESULT', 'citation': 'Castro-Alves LJ, Oliveira de Medeiros AC, Neves SP, Carneiro de Albuquerque CL, Modolo NS, De Azevedo VL, De Oliveira GS Jr. Perioperative Duloxetine to Improve Postoperative Recovery After Abdominal Hysterectomy: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study. Anesth Analg. 2016 Jan;122(1):98-104. doi: 10.1213/ANE.0000000000000971.'}, {'pmid': '27387351', 'type': 'RESULT', 'citation': 'YaDeau JT, Brummett CM, Mayman DJ, Lin Y, Goytizolo EA, Padgett DE, Alexiades MM, Kahn RL, Jules-Elysee KM, Fields KG, Goon AK, Gadulov Y, Westrich G. Duloxetine and Subacute Pain after Knee Arthroplasty when Added to a Multimodal Analgesic Regimen: A Randomized, Placebo-controlled, Triple-blinded Trial. Anesthesiology. 2016 Sep;125(3):561-72. doi: 10.1097/ALN.0000000000001228.'}, {'pmid': '20573635', 'type': 'RESULT', 'citation': 'Ho KY, Tay W, Yeo MC, Liu H, Yeo SJ, Chia SL, Lo NN. Duloxetine reduces morphine requirements after knee replacement surgery. Br J Anaesth. 2010 Sep;105(3):371-6. doi: 10.1093/bja/aeq158. Epub 2010 Jun 23.'}, {'pmid': '25222675', 'type': 'RESULT', 'citation': 'Wong K, Phelan R, Kalso E, Galvin I, Goldstein D, Raja S, Gilron I. Antidepressant drugs for prevention of acute and chronic postsurgical pain: early evidence and recommended future directions. Anesthesiology. 2014 Sep;121(3):591-608. doi: 10.1097/ALN.0000000000000307.'}, {'pmid': '10740540', 'type': 'RESULT', 'citation': 'Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the investigators of the study is to evaluate the effect of peri-operative duloxetine on post-operative recovery in patients undergoing laparoscopic hysterectomy.', 'detailedDescription': 'Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study. After randomization, the study participants will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery, whereas the control participants will be given placebo tablets.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study\n\nExclusion Criteria:\n\n* Patients with chronic non-gynecologic conditions (liver or pulmonary disease, diabetes), using psychiatric drugs (anti-depressants, neuroleptics, lithium) in the last 1 year, those with duloxetine allergy, and patients using opioids for gynecologic or non-gynecologic conditions will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03350334', 'briefTitle': 'Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Prospective Randomized Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'Ob&Gyn Maslak'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Duloxetine', 'description': 'The patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery.', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'The patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta'], 'description': 'Peri-operative Duloxetine administration', 'armGroupLabels': ['Duloxetine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo administration', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34457', 'city': 'Sarıyer', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Maslak Hospital', 'geoPoint': {'lat': 41.16667, 'lon': 29.05}}], 'overallOfficials': [{'name': 'Mete Gungor, MD,Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Acibadem Maslak Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD sharing plan will be made at the end of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.,Assist. Prof, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Ozguc Takmaz', 'investigatorAffiliation': 'Acibadem University'}}}}