Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-01 @ 3:20 PM
Study NCT ID:
NCT00353704
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2006-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Analgetic and Anxiolytic Effect of Preoperative Pregabalin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ulispreng@hotmail.com', 'phone': '004798499184', 'title': 'Ulrich J Spreng', 'organization': 'Baerum Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '14.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes after surgery', 'description': 'The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Morphine (Opioid) Consumption Cumulated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '240 minutes', 'description': 'Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as " cumulated opioid consumption (milligram)', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin'}, {'id': 'FG001', 'title': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'recruitment period november 2005 until june 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin'}, {'id': 'BG001', 'title': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '11', 'groupId': 'BG000'}, {'value': '43', 'spread': '8', 'groupId': 'BG001'}, {'value': '43', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2006-07-17', 'resultsFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2006-07-18', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-19', 'studyFirstPostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)', 'timeFrame': '120 minutes after surgery', 'description': 'The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Morphine (Opioid) Consumption Cumulated', 'timeFrame': '240 minutes', 'description': 'Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as " cumulated opioid consumption (milligram)'}]}, 'conditionsModule': {'keywords': ['Intervertebral disk displacement', 'disk prolapse', 'pregabalin'], 'conditions': ['Intervertebral Disk Displacement', 'Disk Prolapse']}, 'referencesModule': {'references': [{'pmid': '8346839', 'type': 'BACKGROUND', 'citation': 'Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.'}, {'pmid': '15845693', 'type': 'BACKGROUND', 'citation': 'Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.'}, {'pmid': '12218520', 'type': 'BACKGROUND', 'citation': 'Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.'}, {'pmid': '21385158', 'type': 'DERIVED', 'citation': 'Spreng UJ, Dahl V, Raeder J. Effect of a single dose of pregabalin on post-operative pain and pre-operative anxiety in patients undergoing discectomy. Acta Anaesthesiol Scand. 2011 May;55(5):571-6. doi: 10.1111/j.1399-6576.2011.02410.x. Epub 2011 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain.\n\nFurthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.', 'detailedDescription': 'The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. Pregabalin (S-aminomethyl-5-methylhexaninacid) is a further development of gabapentin. Pregabalin has a fewer side-effects compared with gabapentin.\n\nThe purpose of this study is to compare the analgetic and anxiolytic effect of pregabalin and placebo used as premedication.\n\nThe hypothesis is that a single-dose pregabalin (150 mg postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo.\n\nThe study is including patients undergoing surgery of the vertebral columna.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of disc prolapse\n* Age 18+\n* ASA (American Association in Anesthesiology) I-III\n* written consent\n\nExclusion Criteria:\n\n* Age \\< 18\n* ASA \\> III\n* liver failure\n* renal failure\n* allergic reaction against gabapentin and/or pregabalin\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00353704', 'briefTitle': 'Analgetic and Anxiolytic Effect of Preoperative Pregabalin', 'organization': {'class': 'OTHER', 'fullName': 'Asker & Baerum Hospital'}, 'officialTitle': 'Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna', 'orgStudyIdInfo': {'id': '2005-003229-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': '150 mg Pregabalin per orally about one hour before surgery', 'interventionNames': ['Drug: pregabalin', 'Drug: morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One capsule of saccharose (placebo) was administered orally about one hour before surgery.', 'interventionNames': ['Drug: Placebo', 'Drug: morphine']}], 'interventions': [{'name': 'pregabalin', 'type': 'DRUG', 'description': 'capsule 150 mg x 1 per orally one hour before surgery', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One capsule of saccharose (placebo) was administered about one hour before surgery', 'armGroupLabels': ['Placebo']}, {'name': 'morphine', 'type': 'DRUG', 'description': 'All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).', 'armGroupLabels': ['Placebo', 'Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1309', 'city': 'Rud', 'country': 'Norway', 'facility': 'Asker and Baerum Hospital', 'geoPoint': {'lat': 60.43333, 'lon': 11.63333}}], 'overallOfficials': [{'name': 'Ulrich J Spreng, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asker and Baerum Hospital, Norway'}, {'name': 'Vegard Dahl, Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asker and Baerum Hospital, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asker & Baerum Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ulrich Johannes Spreng', 'oldOrganization': 'Asker and Baerum Hospital'}}}}