[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440042":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":41,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":41,"enrollmentInfo":74,"targetDuration":41,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":45,"whyStopped":41,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Patients will be administered D5 water intravenously at the same infusion rate (ml\u002Fhr) as the intervention group for 48 hours after major spinal surgery.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention-Intravenous Lidocaine Infusion","EXPERIMENTAL","Will be administered intravenous lidocaine at 1.33mg\u002Fkg\u002Fhr (adjusted body weight) for 48 hours following major spinal surgery.",[19],"Drug: Lidocaine IV",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lidocaine IV","Intravenous lidocaine will be given at 1.33mg\u002Fkg\u002Fhr (adjusted body weight) for 48 hours following major spinal surgery",[15],[27],"Lidocaine, xylocaine",{"type":22,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"D5 water given at an equivalent ml\u002Fhr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery",[9],[32],"Placebo, D5 water",[34],{"name":35,"affiliation":5,"role":36},"Marc A Buren, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","415-476-8369",null,"marc.buren@ucsf.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","San Francisco","California","94143","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.41942,37.77493,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":41,"email":42},"Marc Buren, MD","415-514-3781",{"type":62,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100440042","phase-3-a-clinical-trial-of-intravenous-lidocaine-after-spinal-surgery-to-prevent-delirium-and-reduce-pain-100440042",false,"NCT05010148","A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain","Continuous Post-operative Lidocaine Infusion Following Major Reconstructive Spine Surgery in the Elderly to Minimize Delirium and Opiate Use: A Randomized Control Trial","LIMPP","Inclusion Criteria:\n\n* Elective spinal fusion surgery\n* Estimated length of stay ≥3 days\n* Fluent in English\n\nExclusion Criteria:\n\nSurgical:\n\n* Cervical spine surgery\n* Non-spine surgeries\n\nOther:\n\n* Allergy or intolerance of lidocaine\n* Significant heart disease (2nd or 3rd heart block without a pacemaker, Left ventricular ejection fraction (LVEF) \\\u003C30%, significant arrhythmia \\[Adams-strokes, Wolff-Parkinson-white syndrome\\], concurrent treatment with a class 1 antiarrhythmic or amiodarone)\n* Significant hepatic or renal dysfunction\n* History of uncontrolled seizures\n* Acute porphyria\n* Preoperative usage of long-acting opioids (methadone, buprenorphine, fentanyl patch, ms-contin, oxycontin) or preoperative opioid usage greater than or equal to the equivalent of 60 mg of oral morphine equivalents.\n* Severe cognitive impairment (reported by proxy or a score of \\>5 on the Short Portable Mental Status Questionnaire (SPMSQ))\n* Self-, or proxy-reported physical impairment preventing the subject from consenting or answering questions\n* Evidence of preoperative delirium\n* Participated in Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain (GIPP) or Postoperative Cognition in Older Adult Surgical Patients (PCD) study previously\n* Participating in any other clinical trial",true,"ALL","60 Years",{"count":75,"type":76},278,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","Postoperative delirium is one of the most frequent adverse events following elective non-cardiac surgery and is associated with cognitive impairment at discharge, as well as in-hospital and long-term mortality, however, despite being a well-recognized problem there is a dearth of effective interventions for prevention and management. A modifiable risk factor associated with postoperative delirium is poor postoperative pain control, and by improving the pain regimen the investigators may be able to decrease the incidence and\u002For severity of postoperative delirium. In this study, the investigators seek to study whether a postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium and other opioid-related side effects, following major reconstructive spinal surgery.",[82,83,84],"Postoperative Delirium","Postoperative Pain","Spinal Fusion",[86,87,88],"lidocaine","spinal surgery","opioid sparing","2025-05-05",{"date":91,"type":92},"2025-05-07","ACTUAL",{"date":94,"type":92},"2021-09-17",{"date":96,"type":76},"2027-09",{"name":5,"class":6},1]