Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-29 @ 6:50 AM
Study NCT ID:
NCT02416804
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2015-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity score : pain NRS scale', 'timeFrame': '3 months', 'description': 'We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['buprenorphine', 'transdermal system', 'Pain, postoperative', 'Quality of life', 'Spinal stenosis', 'Posterior lumbar fusion'], 'conditions': ['Spinal Stenosis', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '28730328', 'type': 'DERIVED', 'citation': 'Kim HJ, Ahn HS, Nam Y, Chang BS, Lee CK, Yeom JS. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial. Eur Spine J. 2017 Nov;26(11):2961-2968. doi: 10.1007/s00586-017-5213-5. Epub 2017 Jul 20.'}]}, 'descriptionModule': {'briefSummary': "Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine transdermal system (MTDS) among the patients with lumbar spinal disease who was performed the single-level posterior lumbar fusion.\n\nAfter surgery, all the patients apply the patient-controlled analgesia. After three days of surgery, patients are divided into two groups.Group A is an experimental group that administer the BTDS after surgery, and Group B is a control group that take tramadol analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional rescue medicine, acetaminophen.\n\nAfter the surgery, patient's pain score and quality of life would be recorded sequentially. The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months, respectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults over 20 years\n* taking the lumbar spinal surgery : single-level, posterior fusion\n* stay in hospital more than 2 days after operation\n\nExclusion Criteria:\n\n* pregnancy or breast-feeding\n* allergy or contraindication to buprenorphine\n* patient with decreased lung function\n* patient with taking MAO inhibitor or anticonvulsant\n* patient with brain lesion, or severe liver disease\n* dependence in opioid drugs\n* taking muscle relaxant or tranquilizer\n* patient had taken buprenorphine preoperatively\n* taking strong opioids before enrolling the study\n* another severe source of pain except lumbar spine\n* severe cardiovascular, pulmonary, or renal compromised patients'}, 'identificationModule': {'nctId': 'NCT02416804', 'briefTitle': 'Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery', 'orgStudyIdInfo': {'id': 'BTDS_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buprenorphine', 'description': 'Buprenorphine group : They will apply 3 days after the spine operation.', 'interventionNames': ['Drug: Buprenorphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol', 'description': 'Tramadol group : They will take a pill of tramadol analgesics.', 'interventionNames': ['Drug: Tramadol']}], 'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG', 'otherNames': ['Norspan'], 'description': 'Buprenorphine transdermal patch Initial : 5 μg/hr Sequential increasing of dose : 5 μg/hr -\\> 10 μg/hr -\\> 15 (5+10) μg/hr -\\> 20 μg/hr', 'armGroupLabels': ['Buprenorphine']}, {'name': 'Tramadol', 'type': 'DRUG', 'otherNames': ['Zytram'], 'description': 'Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -\\> 200 mg/d -\\> 250 mg/d -\\> 300 mg/d', 'armGroupLabels': ['Tramadol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Ho-Joong Kim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin S. Yeom', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}