[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100339184":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":49,"responsibleParty":65,"collaborators":12,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":12,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":12,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":12,"overallStatus":51,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Lahey Clinic","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Traditional Pain Control Care","NO_INTERVENTION","Standard of care post-operative pain control with oral narcotics",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Regional Anesthesia","EXPERIMENTAL","Single injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system",[18],"Drug: Regional Anesthesia",{"label":20,"type":15,"description":21,"interventionNames":22},"Long-Acting Local Anesthesia","Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system",[23],"Drug: Long-Acting Local Anesthesia",[25,31],{"type":26,"name":20,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","The cocktail consists of:\n\n* 0.5% Ropivicaine, 24.6 mL\n* Clonidine 100 mcg\u002FmL, 0.4mL\n* Epinephrine 1mg\u002FmL, 0.5mL\n* Saline to total volume of 50 mL (24.5mL of saline)\n\nThe total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded.",[20],[30],"Local Cocktail",{"type":26,"name":14,"description":32,"armGroupLabels":33,"otherNames":34},"0.5% ropivicaine - 30mL each sciatic and femoral\u002Fsaphenous nerve, ultrasound guided",[14],[35],"Ropivicaine",[37],{"name":38,"affiliation":39,"role":40},"Eric Swart, MD","Lahey Hospital & Medical Center","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":12,"email":45},"CONTACT","781-744-2629","eric.f.swart@lahey.org",{"name":47,"role":43,"phone":44,"phoneExt":12,"email":48},"Jillian Kazley, MD","jillian.kazley@lahey.org",[50],{"facility":39,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Burlington","Massachusetts","01805","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-71.19561,42.50482,{"lat":61,"lon":60},[64],{"name":38,"role":43,"phone":44,"phoneExt":12,"email":12},{"type":40,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Eric Francis Swart","Principal Investigator","100339184","phase-4-randomized-controlled-trial-for-ankle-fracture-pain-control-100339184",false,"NCT03696199","Randomized Controlled Trial for Ankle Fracture Pain Control","A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures","Inclusion Criteria:\n\n* Sustained a bimalleolar ankle fracture (OTA\u002FAO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned Syndesmotic injuries will be included, due to the practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included\n* Isolated Injury\n\nExclusion Criteria:\n\n* Unifocal malleolar fractures\n* Bimalleolar fractures where fixation of only one malleolus is planned\n* Posterior malleolus fractures requiring fixation\n* Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)\n* Open injury\n* Patients treated with external fixation\n* Neurologic condition that would confound results (e.g. peripheral neuropathy)\n* Inability to consent\n* Chronic opioid use\n* History of opiate abuse\n* Polytrauma as defined as additional boney injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)\n* Prisoners (unlikely to be accessible for follow-up)\n* Pregnant patients\n* Non-English-speaking subjects (post-operative data collection procedure involves conversations via phone calls. As we do not have access to translators for this research project, we will work exclusively with English-speaking subjects).\n* Subjects unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.","ALL","18 Years","89 Years",{"count":79,"type":80},70,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic \"cocktail\" in patients undergoing operative fixation of ankle fractures.",[86],"Ankle Fractures","2025-11-03",{"date":89,"type":90},"2025-11-06","ACTUAL",{"date":92,"type":90},"2020-09-01",{"date":94,"type":80},"2027-09-01",{"name":5,"class":6},1]