Nctid:
NCT06236035
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>1}, "targetDuration"=>"1 Day", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-03-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-02-04", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-31", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-07", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"intraoperatively total opioid consumption", "timeFrame"=>"during the surgery", "description"=>"total remifentanil consumption during surgery"}], "secondaryOutcomes"=>[{"measure"=>"pain scores", "timeFrame"=>"up to 24 hours after surgery", "description"=>"assessment pain scores by numeric rating scale (min:0, max:10)"}, {"measure"=>"postoperatif analgesic requirement", "timeFrame"=>"up to 24 hours after surgery", "description"=>"need for analgesics after surgery"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Analgesia nociception index", "opioid consumption", "Pain management"], "conditions"=>["Pain Monitoring", "Pain Assessment", "Opioid Consumption"]}, "descriptionModule"=>{"briefSummary"=>"Osteoarthritis of the knee joint is common and total knee arthroplasty (TKA) is performed in patients with advanced joint degeneration, no response to conservative treatments, severe pain and joint instability. Severe pain levels between 4 and 8 in visual analog pain scale (VAS) scores have been reported in the postoperative period. Multimodal analgesia is considered to be the best option for pain control after total knee arthroplasty. Multimodal analgesia is defined as the combined use of different analgesia techniques such as neuraxial analgesia, peripheral nerve blocks, patient-controlled analgesia and different analgesic drugs. For this purpose, peripheral nerve blocks are effectively applied as a component of multimodal analgesia. Thus, side effects such as nausea, vomiting, pruritus and sedation that may occur due to opioid use are reduced. At the same time, in addition to providing effective analgesia, peripheral blocks contribute to early initiation of rehabilitation of the knee joint, early ambulation, reduction of pulmonary complications and early discharge from the hospital.\n\nRecently, objective methods such as skin vasomotor reflex analysis, pupilometry, pulse plethysmographic signals and analgesia nociceptive index (ANI) have been used to standardize the need for intraoperative analgesia in patients under general anesthesia. Among these methods, ANI is a non-invasive method that provides continuous measurement of parasympathetic tone, which is a part of the autonomic nervous system. Electrodes are placed on the chest wall on both sides of the heart and the patient is monitored.\n\nThe investigators aimed to compare the analgesia nociception index (ANI) and the conventional method to determine perioperative analgesic needs in patients undergoing total knee arthroplasty under general anesthesia with femoral nerve block."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"18-75 years old, ASA I-II-III risk group, undergo knee operation under general anesthesia", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1.18-75 years old, 2.ASA I-II-III risk group 3.undergo knee operation under general anesthesia 4. Patients with preoperative femoral nerve block 5. Patients whose informed consent was read and consent was obtained from them and their guardian\n\nExclusion Criteria:\n\n1. Those who do not want to participate in the study,\n2. ASA IV-V patients\n3. Those with central or autonomic nervous system disease"}, "identificationModule"=>{"nctId"=>"NCT06236035", "briefTitle"=>"Intraoperative Analgesia Based on ANI", "organization"=>{"class"=>"OTHER", "fullName"=>"Zonguldak Bulent Ecevit University"}, "officialTitle"=>"Intraoperative Analgesia Management by Monitoring Analgesia Nociception Index (ANI) in Total Knee Arthroplasty With Femoral Nerve Block: a Randomized Controlled Study", "orgStudyIdInfo"=>{"id"=>"2022/04-21"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Group Control"}, {"label"=>"Group ANI", "interventionNames"=>["Device: Analgesia nociception index"]}], "interventions"=>[{"name"=>"Analgesia nociception index", "type"=>"DEVICE", "description"=>"a device to assess patient's pain during surgery", "armGroupLabels"=>["Group ANI"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"67600", "city"=>"Zonguldak", "state"=>"Kozlu", "country"=>"Turkey", "facility"=>"Zonguldak Bülent Ecevit University", "geoPoint"=>{"lat"=>41.45139, "lon"=>31.79305}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Zonguldak Bulent Ecevit University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Keziban Bollucuoglu", "investigatorAffiliation"=>"Zonguldak Bulent Ecevit University"}}}}
