[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474683":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":112,"centralContacts":117,"locations":126,"responsibleParty":140,"collaborators":42,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":42,"eligibilityCriteria":147,"healthyVolunteers":144,"sex":148,"minAge":149,"maxAge":42,"enrollmentInfo":150,"targetDuration":42,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":42,"overallStatus":128,"whyStopped":42,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.","ACTIVE_COMPARATOR","Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29],"Diagnostic Test: Blood Test","Other: 3D CAM Delirium Severity Scoring","Other: Generalized Anxiety Disorder 7-item (GAD-7) scale","Other: Numerical Rating Score (NRS)","Other: PROMIS-Pain Interference","Other: Oswestry Disability Index (ODI)","Other: Saint Louis University Mental Status Examination (SLUMs)","Other: Delirium Rating Scale-Revised-98 (DRS)","Other: Telephone Interview for Cognitive Status - Modified (TICS-M)","Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME)","Other: Patient Health Questionnaire depression scale (PHQ-8)","Other: Pain Catastrophizing","Other: Fear Avoidance Beliefs Questionnaire (FABQ)","Other: Opioid Side Effects and Likeability Questionnaire","Other: Daily Pain Trajectory","Other: Tampa Scale of Kinesiophobia","Other: Quality of Recovery 15",{"label":31,"type":32,"description":33,"interventionNames":34},"Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine","EXPERIMENTAL","Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.",[35,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29],"Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine",[37,43,48,52,56,60,64,68,72,76,80,84,88,92,96,100,104,108],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine","Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.",[31],null,{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":42},"DIAGNOSTIC_TEST","Blood Test","Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa",[31,9],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":42},"3D CAM Delirium Severity Scoring","Questionnaire that will rate each symptom of delirium",[31,9],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":42},"Generalized Anxiety Disorder 7-item (GAD-7) scale","Questionnaire for screening and severity measurement of generalized anxiety disorder.",[31,9],{"type":6,"name":57,"description":58,"armGroupLabels":59,"otherNames":42},"Numerical Rating Score (NRS)","Questionnaire assessing pain intensity",[31,9],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":42},"PROMIS-Pain Interference","Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.",[31,9],{"type":6,"name":65,"description":66,"armGroupLabels":67,"otherNames":42},"Oswestry Disability Index (ODI)","Questionnaire assessing disability and quality of life impairment in adults with lower back pain.",[31,9],{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":42},"Saint Louis University Mental Status Examination (SLUMs)","Questionnaire assessing baseline cognition.",[31,9],{"type":6,"name":73,"description":74,"armGroupLabels":75,"otherNames":42},"Delirium Rating Scale-Revised-98 (DRS)","16 item clinician rated scale assessing delirium severity.",[31,9],{"type":6,"name":77,"description":78,"armGroupLabels":79,"otherNames":42},"Telephone Interview for Cognitive Status - Modified (TICS-M)","Telephone interview questionnaire evaluating patient cognitive status.",[31,9],{"type":6,"name":81,"description":82,"armGroupLabels":83,"otherNames":42},"Opioid Equivalents measured by Morphine Milligram Equivalents (MME)","The amount of opioids administered will be collected through patient self-report",[31,9],{"type":6,"name":85,"description":86,"armGroupLabels":87,"otherNames":42},"Patient Health Questionnaire depression scale (PHQ-8)","Questionnaire used to diagnose and determine the severity measure for depressive disorders.",[31,9],{"type":6,"name":89,"description":90,"armGroupLabels":91,"otherNames":42},"Pain Catastrophizing","Scale used to determine pain catastrophizing and it's severity.",[31,9],{"type":6,"name":93,"description":94,"armGroupLabels":95,"otherNames":42},"Fear Avoidance Beliefs Questionnaire (FABQ)","Questionnaire used to help predict patients that have a high pain avoidance behavior.",[31,9],{"type":6,"name":97,"description":98,"armGroupLabels":99,"otherNames":42},"Opioid Side Effects and Likeability Questionnaire","Survey determining adverse events related to opioid side effects and complications.",[31,9],{"type":6,"name":101,"description":102,"armGroupLabels":103,"otherNames":42},"Daily Pain Trajectory","Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.",[31,9],{"type":6,"name":105,"description":106,"armGroupLabels":107,"otherNames":42},"Tampa Scale of Kinesiophobia","Questionnaire assessing Kinesiophobia",[31,9],{"type":6,"name":109,"description":110,"armGroupLabels":111,"otherNames":42},"Quality of Recovery 15","Questionnaire assessing postoperative quality of recovery",[31,9],[113],{"name":114,"affiliation":115,"role":116},"Catherine R Olinger, MD","Clinical Assistant Professor","PRINCIPAL_INVESTIGATOR",[118,123],{"name":119,"role":120,"phone":121,"phoneExt":42,"email":122},"Alex R Coffman, BS","CONTACT","319-353-8996","alex-coffman@uiowa.edu",{"name":114,"role":120,"phone":124,"phoneExt":42,"email":125},"319-384-5892","catherine-olinger@uiowa.edu",[127],{"facility":5,"status":128,"city":129,"state":130,"zip":131,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":139,"contacts":42},"RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":135,"coordinates":136},"Point",[137,138],-91.53017,41.66113,{"lat":138,"lon":137},{"type":116,"investigatorFullName":141,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Catherine R. Olinger","100474683","early-phase-1-regional-nerve-blocks-to-improve-analgesia-and-recovery-in-older-adults-undergoing-spinal-fusion-100474683",false,"NCT05461092","Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion","Inclusion Criteria:\n\n* Are 65 or older\n* Indicated for lumbar spinal fusion of less than or equal to 3 levels\n* Undergoing elective surgery\n* no contraindications to local anesthetic or procedures\n* no severe cardiac or respiratory disease\n* no preexisting cognitive dysfunction\u002Fdementia\n\nExclusion Criteria:\n\n* 64 years old and younger\n* emergency treatment\n* pathologic fractures\n* seeking revision surgery\n* major liver or kidney dysfunction\n* coexisting hematological disorder or irreversible abnormal coagulation\n* patients with previous diagnosis of dementia or SLUMS score \\\u003C20\n* patient unable to communicate\u002Fcooperate\u002Flanguage barrier\n* BMI\\>40\n* allergy to study medications\n* opioid tolerant (oral opioid intake morphine equivalent =\\\u003C 60 mg\u002Fday)\n* other sources of chronic pain like fibromyalgia\n* patients with associated significant CNS or respiratory disease (home oxygen requirements)\n* incarcerated patients\n* psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions\n* pregnant or breast feeding","ALL","65 Years",{"count":151,"type":152},50,"ESTIMATED","INTERVENTIONAL",[155],"EARLY_PHASE1","This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.",[158,159,160,161],"Delirium","Pain, Back","Spinal Fusion","Thoracolumbar Interfascial Plane Block","2026-03-24",{"date":164,"type":165},"2026-03-27","ACTUAL",{"date":167,"type":165},"2024-01-01",{"date":169,"type":152},"2026-12-31",{"name":5,"class":6},1]