{"protocolSection":{"identificationModule":{"nctId":"NCT02535000","orgStudyIdInfo":{"id":"1"},"organization":{"fullName":"Serviço de Anestesiologia de Joinville","class":"OTHER"},"briefTitle":"Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery","officialTitle":"Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery","acronym":"Duloxetine"},"statusModule":{"statusVerifiedDate":"2020-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-01-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-10-20","type":"ACTUAL"},"completionDateStruct":{"date":"2015-10-30","type":"ACTUAL"},"studyFirstSubmitDate":"2015-08-23","studyFirstSubmitQcDate":"2015-08-25","studyFirstPostDateStruct":{"date":"2015-08-28","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-08-11","resultsFirstSubmitQcDate":"2020-09-13","resultsFirstPostDateStruct":{"date":"2020-10-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-09-13","lastUpdatePostDateStruct":{"date":"2020-10-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"antonio bedin","investigatorTitle":"MD","investigatorAffiliation":"Serviço de Anestesiologia de Joinville"},"leadSponsor":{"name":"Serviço de Anestesiologia de Joinville","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.","detailedDescription":"Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness."},"conditionsModule":{"conditions":["Intervertebral Disc Degeneration"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"SUPPORTIVE_CARE","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Group C (control)","type":"EXPERIMENTAL","description":"subjects who will receive one capsule of placebo before the surgery and being repeated the next day","interventionNames":["Drug: Placebo"]},{"label":"Group D (duloxetine)","type":"ACTIVE_COMPARATOR","description":"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"duloxetine 60 mg","armGroupLabels":["Group D (duloxetine)"],"otherNames":["Cymbalta"]},{"type":"DRUG","name":"Placebo","description":"placebo","armGroupLabels":["Group C (control)"],"otherNames":["inactive substance"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.","description":"The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.","timeFrame":"up to 2 days."}],"secondaryOutcomes":[{"measure":"Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).","description":"At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score.","timeFrame":"up to 2 days."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study\n\nExclusion Criteria:\n\n* Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"referencesModule":{"references":[{"pmid":"28002096","type":"RESULT","citation":"Bedin A, Caldart Bedin RA, Vieira JE, Ashmawi HA. Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study. Clin J Pain. 2017 Oct;33(10):865-869. doi: 10.1097/AJP.0000000000000471."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The study was started in January, 2014 at the Centro Hospitalar Unimed of Joinville, Brazil","groups":[{"id":"FG000","title":"Group C (Control)","description":"subjects who will receive one capsule of placebo before the surgery and being repeated the next day\n\nPlacebo: placebo"},{"id":"FG001","title":"Group D (Duloxetine)","description":"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day\n\nDuloxetine: duloxetine 60 mg"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Cancellation of surgery.","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Group C (Control)","description":"subjects who will receive one capsule of placebo before the surgery and being repeated the next day\n\nPlacebo: placebo"},{"id":"BG001","title":"Group D (Duloxetine)","description":"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day\n\nDuloxetine: duloxetine 60 mg"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"57"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"57"}]}],"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"57"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"57"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"31"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"26"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Brazil","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"57"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"57"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.","description":"The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.","populationDescription":"At the beginning of the trial, Group C would have 30 patients and D also 30 patients. However, 1 patient in Group C and 2 patients in group D were excluded due to cancellation of the proposed surgery, after patient receiving 60 mg of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"micrograms","timeFrame":"up to 2 days.","groups":[{"id":"OG000","title":"Group C (Control)","description":"subjects who will receive one capsule of placebo before the surgery and being repeated the next day\n\nPlacebo: placebo"},{"id":"OG001","title":"Group D (Duloxetine)","description":"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day\n\nDuloxetine: duloxetine 60 mg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Fentanyl consumption in between 0 and 24 hours.","categories":[{"measurements":[{"groupId":"OG000","value":"726","spread":"36"},{"groupId":"OG001","value":"503","spread":"19"}]}]},{"title":"Fentanyl consumption in between 24 and 48 hours.","categories":[{"measurements":[{"groupId":"OG000","value":"180","spread":"20"},{"groupId":"OG001","value":"136","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).","description":"At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score.","populationDescription":"At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Number (pain score range 0 to 10).","timeFrame":"up to 2 days.","groups":[{"id":"OG000","title":"Group C (Control)","description":"subjects who will receive one capsule of placebo before the surgery and being repeated the next day\n\nPlacebo: placebo"},{"id":"OG001","title":"Group D (Duloxetine)","description":"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day\n\nDuloxetine: duloxetine 60 mg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Pain score 2 hours after surgery.","categories":[{"measurements":[{"groupId":"OG000","value":"2.27","spread":"2.67"},{"groupId":"OG001","value":"2.14","spread":"2.04"}]}]},{"title":"pain score 6 hours after surgery","categories":[{"measurements":[{"groupId":"OG000","value":"2.67","spread":"2.44"},{"groupId":"OG001","value":"2.28","spread":"2.07"}]}]},{"title":"Pain score 12 hours after surgery.","categories":[{"measurements":[{"groupId":"OG000","value":"2.10","spread":"2.31"},{"groupId":"OG001","value":"2.07","spread":"1.92"}]}]},{"title":"Pain score 24 hours after surgery.","categories":[{"measurements":[{"groupId":"OG000","value":"1.68","spread":"2.13"},{"groupId":"OG001","value":"1.66","spread":"1.64"}]}]},{"title":"Pain score 36 hours after surgery.","categories":[{"measurements":[{"groupId":"OG000","value":"1.48","spread":"2.06"},{"groupId":"OG001","value":"1.37","spread":"1.52"}]}]},{"title":"Pain score 48 hours after surgery.","categories":[{"measurements":[{"groupId":"OG000","value":"1.51","spread":"2.08"},{"groupId":"OG001","value":"1.07","spread":"1.03"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"1","timeFrame":"Two days.","description":"Incidence of adverse effects accessed in the first two postoperative days.","eventGroups":[{"id":"EG000","title":"Group C (Control)","description":"subjects who will receive one capsule of placebo before the surgery and being repeated the next day\n\nPlacebo: placebo","deathsNumAffected":0,"deathsNumAtRisk":29,"seriousNumAffected":0,"seriousNumAtRisk":29,"otherNumAffected":10,"otherNumAtRisk":29},{"id":"EG001","title":"Group D (Duloxetine)","description":"subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day\n\nDuloxetine: duloxetine 60 mg","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":9,"otherNumAtRisk":28}],"otherEvents":[{"term":"somnolence","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":29},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":28}]},{"term":"itching","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":29},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":28}]},{"term":"nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":29},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":28}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":28}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"We used the same dose as previous investigators. We did not evaluate a possible effect of duloxetine on chronic postsurgical pain."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Antonio Bedin","organization":"Serviço de Anestesiologia de Joinville","email":"abjoimailbox-ct@yahoo.com","phone":"+554734331666"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D055959","term":"Intervertebral Disc Degeneration"}],"ancestors":[{"id":"D013122","term":"Spinal Diseases"},{"id":"D001847","term":"Bone Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"}]},"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"}]}},"hasResults":true}