[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460704":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bupivacaine-Liposomal Bupivacaine (B-LB)","ACTIVE_COMPARATOR","Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an Interspace between the popliteal artery and capsule of the posterior knee (iPACK) block.",[13],"Drug: Bupivacaine-Liposomal Bupivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)","EXPERIMENTAL","Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block.",[19],"Drug: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacaine-Liposomal Bupivacaine","Adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an iPACK block",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate","Adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block.",[15],[32],{"name":33,"affiliation":5,"role":34},"Jinlei Li, MD PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","475-434-4038","jinlei.li@yale.edu",[41,57],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Yale New Haven Hospital Saint Raphael Campus","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-72.92816,41.30815,{"lat":53,"lon":52},[56],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"facility":58,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Yale New Haven Hospital York Street Campus",{"type":50,"coordinates":60},[52,53],{"lat":53,"lon":52},[63],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[67],{"name":68,"class":69},"Department of Anesthesiology Faculty Development Fund","UNKNOWN","100460704","phase-2-yale-steroid-enhanced-versus-exparel-nerveblock-tka-rct-study-100460704",false,"NCT05279092","Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study","Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study","Yale SEVEN","Inclusion Criteria:\n\n* American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.\n\nExclusion Criteria:\n\n* Refusal of consent\n* Pregnancy\n* Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically\n* Coagulopathy\n* Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB\n* Patients on any amounts of opioids within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month)\n* Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose \\>200mg\u002Fdl, or HbA1C \\> 8.0%\n* Peripheral Nerve Block site or systemic infection\n* Immune compromise (e.g., HIV, chronic glucocorticoid use)\n* Severe pre-existing neuropathy\n* TKA for indications other than osteoarthritis such as post-traumatic injury or rheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKA or bilateral TKA\n* Severe hepatic or renal dysfunction (GFR \\\u003C50 ml\u002Fmin)\n* Actual body weight \\\u003C60 kg\n* Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis","ALL","18 Years",{"count":81,"type":82},250,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB.\n\nThis study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.",[88,89],"Total Knee Replacement","Knee Arthroplasty","2025-05-13",{"date":92,"type":93},"2025-05-14","ACTUAL",{"date":95,"type":93},"2022-09-08",{"date":97,"type":82},"2028-03",{"name":5,"class":6},2]