[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495849":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":41,"enrollmentInfo":82,"targetDuration":41,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":41,"overallStatus":46,"whyStopped":41,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Yale University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"B-LB in left knee and B-DEX-MPA in right knee","EXPERIMENTAL","Participants in this arm will receive B-LB in their left knee and B-DEX-MPA in their right knee.\n\nNerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.\n\nNerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.",[13,14],"Drug: Bupivacaine-Liposomal Bupivacaine","Drug: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate",{"label":16,"type":10,"description":17,"interventionNames":18},"B-LB in right knee and B-DEX-MPA in left knee","Participants in this arm will receive B-LB in their right knee and B-DEX-MPA in their left knee.\n\nNerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.\n\nNerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Bupivacaine-Liposomal Bupivacaine","A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.",[9,16],[26],"B-LB",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate","A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.",[9,16],[32],"B-DEX-MPA",[34],{"name":35,"affiliation":5,"role":36},"Jinlei Li, MD PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","475-434-4038",null,"jinlei.li@yale.edu",[44,60],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Yale New Haven Hospital Saint Raphael Campus","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-72.92816,41.30815,{"lat":56,"lon":55},[59],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"facility":61,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Yale New Haven Hospital York Street Campus",{"type":53,"coordinates":63},[55,56],{"lat":56,"lon":55},[66],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":68,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[70],{"name":71,"class":72},"Department of Anesthesiology Faculty Development Fund","UNKNOWN","100495849","phase-2-yale-steroid-enhanced-versus-exparel-nerveblock-tka-part-2-100495849",false,"NCT05736549","Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2","Yale SEVEN","Inclusion Criteria:\n\n* American Society of Anesthesiologists status I, II and III, elective, primary, bilateral 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":83,"type":84},66,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral 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.",[90,91],"Total Knee Replacement","Knee Arthroplasty","2025-05-13",{"date":94,"type":95},"2025-05-14","ACTUAL",{"date":97,"type":95},"2023-02-07",{"date":99,"type":84},"2028-03",{"name":5,"class":6},2]