[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502598":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":50,"locations":57,"responsibleParty":90,"collaborators":76,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":76,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":79,"whyStopped":76,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Fraser Health","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"General anesthesia with endotracheal tube","ACTIVE_COMPARATOR","Currently the standard at our centre. Participants in this group will undergo lower lumbar surgery with general anesthesia with endotracheal intubation.",[13],"Drug: General anesthesia for lumbar surgery",{"label":15,"type":10,"description":16,"interventionNames":17},"Spinal anesthesia with bupivacaine","Participants in this group will undergo lower lumbar surgery under spinal anesthesia with bupivacaine 0.5% 10-15 mg with fentanyl 10-15 mcg.",[18],"Drug: Spinal anesthesia for lumbar surgery: bupivacaine",{"label":20,"type":21,"description":22,"interventionNames":23},"Spinal anesthesia with ropivacaine","EXPERIMENTAL","Participants in this group will undergo lower lumbar surgery under spinal anesthesia with ropivacaine 0.5% 10-20 mg with fentanyl 10-15 mcg.",[24],"Drug: Spinal anesthesia for lumbar surgery: ropivacaine",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Spinal anesthesia for lumbar surgery: ropivacaine","The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally",[20],[32],"Ropivacaine in the spinal anesthesia for lower lumbar surgery",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Spinal anesthesia for lumbar surgery: bupivacaine","The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.",[15],[38],"Bupivacaine in the spinal anesthesia for lower lumbar surgery",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"General anesthesia for lumbar surgery","Patient will be intubated and ventilated under general anesthesia.",[9],[44],"General Anesthesia with Endotracheal intubation",[46],{"name":47,"affiliation":48,"role":49},"Alan Tung, MD","Anesthesiologist","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Michelle Mozel, MSc.","CONTACT","604-520-4253","523414","michelle.mozel@fraserhealth.ca",[58,77],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Royal Columbian Hospital","NOT_YET_RECRUITING","New Westminster","British Columbia","V3L 3W7","Canada","CA",{"type":67,"coordinates":68},"Point",[69,70],-122.91092,49.20678,{"lat":70,"lon":69},[73,75],{"name":74,"role":53,"phone":54,"phoneExt":55,"email":56},"Michelle Mozel, MSc",{"name":47,"role":49,"phone":76,"phoneExt":76,"email":76},null,{"facility":78,"status":79,"city":80,"state":62,"zip":81,"country":64,"countryCode":65,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Eagle Ridge Hospital","RECRUITING","Port Moody","V3H 3W9",{"type":67,"coordinates":83},[84,85],-122.82457,49.28124,{"lat":85,"lon":84},[88,89],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},{"name":47,"role":49,"phone":76,"phoneExt":76,"email":76},{"type":49,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":76,"oldOrganization":76},"Alan Tung","Clinical Instructor","100502598","early-phase-1-testing-the-feasibility-of-using-ropivacaine-in-spinal-anesthesia-for-patients-with-lower-back-surgery-100502598",false,"NCT05824338","Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery","SASS","Inclusion Criteria:\n\n* Adult patients who are equal to or greater than 18 years old\n* Undergoing elective one or two-level lumbar surgery via posterior surgical approach in the prone position (between L2-S1)\n* Expected surgery duration of no greater than 2 hours\n* ASA Physical Status Class 1 to 3\n* Patient can have either spinal anesthesia or general anesthesia\n* Able to provide consent and understand information in English, and capable of answering questions in English\n\nExclusion Criteria:\n\n* Allergy to either ropivacaine, bupivacaine, or local anesthetics\n* Contraindications to spinal anesthesia (i.e. coagulopathy or on anticoagulants, severe aortic or mitral valve stenosis, sepsis or bacteremia, thrombocytopenia, high intracranial pressure, infection at the puncture site)\n* Surgery is expected to take more than 2 hours\n* Emergency surgery\n* Previously had back surgery at the level of the spine currently being operated on\n* Comorbidities that require the patient to undergo general anesthesia\n* Inability to stay still during the surgery\n* Inability to move legs preoperatively\n* Body Mass Index (BMI) \\>35\n* Multilevel severe spinal stenosis","ALL","19 Years","80 Years",{"count":104,"type":105},45,"ESTIMATED","INTERVENTIONAL",[108],"EARLY_PHASE1","The goal of this pilot clinical trial is to test the feasibility of conducting a randomized controlled trial that will examine the use of ropivacaine in the spinal anesthesia for patients undergoing elective 1- or 2-level lower spine surgery. This study aims to:\n\n* Determine the rates of eligibility, recruitment, consent, and attrition\n* Determine the acceptability among patients, surgeons, anesthesiologists, and nurses of doing spine surgery under spinal anesthesia\n* Gather preliminary data on outcomes relevant to a future dose-finding study\n\nParticipants will be randomized to one of three treatment groups:\n\n* General anesthesia with endotracheal tube\n* Spinal anesthesia with bupivacaine\n* Spinal anesthesia with ropivacaine",[111,112,113,114],"Anesthesia, Spinal","Neurosurgery","Ropivacaine","Bupivacaine",[116,117,118,119],"Anesthesia","Spinal","Lumbar surgery","Lower back","2024-10-04",{"date":122,"type":123},"2024-10-08","ACTUAL",{"date":125,"type":123},"2024-08-27",{"date":127,"type":105},"2025-12-31",{"name":5,"class":6},2]