[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06465992":3,"trial-entities:NCT06465992":92,"trial-summary:NCT06465992":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":15,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":75,"locations":78,"central_contacts":88,"overall_officials":89,"references":90,"see_also_links":91},"NCT06465992","DPED20242471","Liposomal Bupivacaine With Dexamethasone for Foot Surgery","Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial","UNKNOWN","2025-06-30","2024-06","2024-06-20","2024-06-17","Rothman Institute Orthopaedics","OTHER",null,"This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.",[18,19,20,21],"Foot Surgery","Ankle Surgery","Post Operative Pain","Popliteal Nerve Block",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},126,"ESTIMATED",[31,38,42],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Exparel 266 MG Per 20 ML Injection","20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block",[36,37],"Study Group 1: Foot\u002FAnkle Surgery with Exparel Nerve Block","Study Group 2: Foot\u002FAnkle Surgery with Exparel + Dexamethasone Nerve Block",{"type":32,"name":39,"description":40,"armGroupLabels":41},"Bupivacaine Hcl 0.75% Inj","10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block",[36,37],{"type":32,"name":43,"description":44,"armGroupLabels":45},"Dexamethasone","1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block",[37],[47,51],{"measure":48,"description":49,"timeFrame":50},"Amount of pain medication used after surgery","Collected as tablets taken since all participants will be prescribed oxycodone","14 days",{"measure":52,"description":53,"timeFrame":50},"Pain level after surgery","Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale",[],"ALL","18 Years",true,{"inclusion":59,"exclusion":66,"raw_text":74},[60,61,62,63,64,65],"Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard","Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block","Age 18 and older","English speaking","Ability to complete surveys by phone or in person","Ability to provide informed consent",[67,68,69,70,71,72,73],"Revision foot and ankle cases","Allergies to study medications","Non-English speakers","Known alcohol or narcotic abuse history","Existing contract with a pain specialist due to underlying preoperative pain syndrome","Preoperative opioid use within the 3 months prior to surgery","Participants who are pregnant, plan to become pregnant, or are breastfeeding.","Inclusion Criteria:\n\n* Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard\n* Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block\n* Age 18 and older\n* English speaking\n* Ability to complete surveys by phone or in person\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Revision foot and ankle cases\n* Allergies to study medications\n* Non-English speakers\n* Known alcohol or narcotic abuse history\n* Existing contract with a pain specialist due to underlying preoperative pain syndrome\n* Preoperative opioid use within the 3 months prior to surgery\n* Participants who are pregnant, plan to become pregnant, or are breastfeeding.",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"geoPoint":85},"Rothman Orthopaedic Institute","Philadelphia","Pennsylvania","19107","United States",{"lat":86,"lon":87},39.95238,-75.16362,[],[],[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94,18],"Acne surgery",[],{"nct_id":4,"found":97,"summary":15,"prompt_version":15},false]