{"protocolSection":{"identificationModule":{"nctId":"NCT00354029","orgStudyIdInfo":{"id":"2006-001082-41"},"organization":{"fullName":"Asker & Baerum Hospital","class":"OTHER"},"briefTitle":"Effect of Perioperative i.v. Low-dose S(+) Ketamine","officialTitle":"Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy"},"statusModule":{"statusVerifiedDate":"2011-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-08"},"primaryCompletionDateStruct":{"date":"2008-06","type":"ACTUAL"},"completionDateStruct":{"date":"2009-05","type":"ACTUAL"},"studyFirstSubmitDate":"2006-07-18","studyFirstSubmitQcDate":"2006-07-18","studyFirstPostDateStruct":{"date":"2006-07-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-05-24","resultsFirstSubmitQcDate":"2011-07-19","resultsFirstPostDateStruct":{"date":"2011-07-20","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-07-19","lastUpdatePostDateStruct":{"date":"2011-07-20","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Ulrich Johannes Spreng","oldOrganization":"Asker and Baerum Hospital"},"leadSponsor":{"name":"Asker & Baerum Hospital","class":"OTHER"}},"descriptionModule":{"briefSummary":"The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain.\n\nFurthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.","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 S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects.\n\nThe purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period.\n\nThe hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function.\n\nThe study is including patients undergoing hemorrhoidectomy."},"conditionsModule":{"conditions":["Hemorrhoids","Pain"],"keywords":["hemorrhoids","hemorrhoidectomy","S (+) ketamine","pain"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":83,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Saline 0,9%","interventionNames":["Drug: Placebo"]},{"label":"S (+) Ketamine","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: S (+) Ketamine"]}],"interventions":[{"type":"DRUG","name":"S (+) Ketamine","description":"0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery","armGroupLabels":["S (+) Ketamine"]},{"type":"DRUG","name":"Placebo","description":"isotonic saline","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"NRS Pain = Numeric Rating Scale (0-10)","description":"The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.","timeFrame":"24 hours"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Clinical diagnosis of disc prolapse\n* Age 18+\n* ASA (American Society in Anesthesiology) I-II\n* written consent\n\nExclusion Criteria:\n\n* Age \\< 18\n* ASA \\> II\n* liver failure\n* renal failure\n* heart failure\n* glaucoma\n* pregnancy","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ulrich J Spreng, Dr. med,","affiliation":"Asker and Baerum Hospital, Norway","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Vegard Dahl, Dr. med.","affiliation":"Asker and Baerum Hospital, Norway","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Asker and Baerum Hospital","city":"Rud","zip":"N-1309","country":"Norway","geoPoint":{"lat":60.43333,"lon":11.63333}}]},"referencesModule":{"references":[{"pmid":"8957979","type":"BACKGROUND","citation":"Arendt-Nielsen L, Nielsen J, Petersen-Felix S, Schnider TW, Zbinden AM. Effect of racemic mixture and the (S+)-isomer of ketamine on temporal and spatial summation of pain. Br J Anaesth. 1996 Nov;77(5):625-31. doi: 10.1093/bja/77.5.625."},{"pmid":"15618805","type":"BACKGROUND","citation":"Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. doi: 10.1097/00000542-200501000-00030. No abstract available."},{"pmid":"16223384","type":"BACKGROUND","citation":"Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. doi: 10.1111/j.1399-6576.2005.00814.x."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"S (+) Ketamine"},{"id":"FG001","title":"Placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"40"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"38"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"S (+) Ketamine"},{"id":"BG001","title":"Placebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"83"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"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":"43"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"83"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.4","spread":"11.6"},{"groupId":"BG001","value":"50.2","spread":"11.4"},{"groupId":"BG002","value":"48","spread":"11.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"48"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"35"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Norway","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"83"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"NRS Pain = Numeric Rating Scale (0-10)","description":"The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"24 hours","groups":[{"id":"OG000","title":"S (+) Ketamine"},{"id":"OG001","title":"Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"2.1"},{"groupId":"OG001","value":"1.5","spread":"1.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"t-test, 2 sided","ciPctValue":"95"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"S (+) Ketamine","seriousNumAffected":0,"seriousNumAtRisk":43,"otherNumAffected":0,"otherNumAtRisk":43},{"id":"EG001","title":"Placebo","seriousNumAffected":0,"seriousNumAtRisk":40,"otherNumAffected":0,"otherNumAtRisk":40}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Ulrich J Spreng","organization":"Baerum Hospital","email":"ulispreng@hotmail.com","phone":"004798499184"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D006484","term":"Hemorrhoids"},{"id":"D010146","term":"Pain"}],"ancestors":[{"id":"D012002","term":"Rectal Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D007649","term":"Ketamine"}],"ancestors":[{"id":"D003510","term":"Cyclohexanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}