[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397367":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":46,"centralContacts":53,"locations":62,"responsibleParty":86,"collaborators":57,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":57,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":57,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":65,"whyStopped":57,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Duke University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Mepivacaine Block Group","EXPERIMENTAL","Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.",[13,14],"Drug: Mepivacaine","Procedure: Perifemoral Injection of Local Anesthetic",{"label":16,"type":17,"description":18,"interventionNames":19},"Saline Sham Group","PLACEBO_COMPARATOR","Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.",[20,14],"Drug: Saline",[22,29,35,42],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Mepivacaine","An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.",[9],[28],"Carbocaine",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Saline","An infiltration of saline superomedially to the femoral artery via perineural catheter.",[16],[34],"Salt water placebo",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"PROCEDURE","Perifemoral Injection of Local Anesthetic","Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.",[9],[41],"Femoral Periarterial Injection",{"type":36,"name":37,"description":43,"armGroupLabels":44,"otherNames":45},"Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.",[16],[41],[47,50],{"name":48,"affiliation":5,"role":49},"Amanda Kumar, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":5,"role":52},"William M Bullock, MD, PhD","STUDY_DIRECTOR",[54,59],{"name":51,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","919-681-6437",null,"william.bullock@duke.edu",{"name":60,"role":55,"phone":56,"phoneExt":57,"email":61},"Jeff C Gadsden, MD","jeff.gadsden@duke.edu",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Duke University Hospital","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-78.89862,35.99403,{"lat":75,"lon":74},[78,79,82,83,85],{"name":51,"role":55,"phone":56,"phoneExt":57,"email":58},{"name":80,"role":55,"phone":56,"phoneExt":57,"email":81},"Amanda Kumar, MD","amanda.kumar@duke.edu",{"name":80,"role":49,"phone":57,"phoneExt":57,"email":57},{"name":51,"role":84,"phone":57,"phoneExt":57,"email":57},"SUB_INVESTIGATOR",{"name":60,"role":84,"phone":57,"phoneExt":57,"email":57},{"type":87,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100397367","phase-4-femoral-peri-arterial-local-anesthetic-injection-via-peri-arterial-perineural-catheter-reverses-tourniquet-associated-ischemic-hypertension-100397367",false,"NCT04454203","Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension","Inclusion Criteria:\n\nPatients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.\n\nExclusion Criteria:\n\n1. ASA 4 or 5\n2. Diagnosis of chronic pain\n3. Daily chronic opioid use (over 3 months of continuous opioid use).\n4. Inability to communicate pain scores or need for analgesia.\n5. Infection at the site of block placement\n6. Age under 18 years old or greater than 75 years old\n7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)\n8. Intolerance\u002Fallergy to local anesthetics\n9. Weight \\\u003C50 kg\n10. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.\n12. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course",true,"ALL","18 Years","75 Years",{"count":99,"type":100},40,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.",[106,107,108,109],"Tourniquet Hypertension","Intraoperative Hypertension","Total Ankle Arthroplasty","Ankle Fusion",[111,112,24,106],"Perifemoral","Tourniquet","2026-03-20",{"date":115,"type":116},"2026-03-23","ACTUAL",{"date":118,"type":116},"2021-02-05",{"date":120,"type":100},"2027-02-03",{"name":5,"class":6},1]