[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06006624":3,"trial-entities:NCT06006624":102,"trial-summary:NCT06006624":106},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":58,"sex":59,"minimum_age":60,"maximum_age":15,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":81,"locations":84,"central_contacts":94,"overall_officials":95,"references":96,"see_also_links":101},"NCT06006624","SHAM2023-2163","Exparel vs Block for ACL Reconstruction","Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial","UNKNOWN","2024-10-30","2024-06","2024-06-21","2023-08-21","Rothman Institute Orthopaedics","OTHER",null,"Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.",[18,19],"ACL","Postoperative Pain",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},154,"ESTIMATED",[29,36,40,44],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Exparel 30 mL","30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block",[34,35],"Group 1: ACL repair + Exparel + nerve block","Group 2: ACL repair + Exparel + Dexamethasone + nerve block",{"type":30,"name":37,"description":38,"armGroupLabels":39},"0.5% bupivacaine","5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal",[34,35],{"type":30,"name":41,"description":42,"armGroupLabels":43},"Dexamethasone","10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal",[35],{"type":30,"name":45,"description":46,"armGroupLabels":47},"iPACK block","iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block",[34,35],[49,52,55],{"measure":19,"description":50,"timeFrame":51},"Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain","14 days",{"measure":53,"description":54,"timeFrame":51},"Postoperative opioid use","assessed using a participant daily diary of how much medication was taken daily for pain",{"measure":56,"description":57,"timeFrame":51},"Postoperative Pain #2","Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain",[],"ALL","18 Years",true,{"inclusion":63,"exclusion":70,"raw_text":80},[64,65,66,67,68,69],"Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons","Primary ACL Reconstruction with Autograft +\u002F- Partial meniscectomy +\u002F- Lateral extra-articular tenodesis","Age 18 and older","English speaking","Ability to complete surveys by phone or in person","Ability to provide informed consent",[71,72,73,74,75,76,77,78,79],"Revision cases","Multi-ligamentous knee injuries","Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol","ACL reconstruction utilizing non-bone-patellar tendon-bone autografts","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","Inclusion Criteria:\n\n* Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons\n* Primary ACL Reconstruction with Autograft +\u002F- Partial meniscectomy +\u002F- Lateral extra-articular tenodesis\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 cases\n* Multi-ligamentous knee injuries\n* Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol\n* ACL reconstruction utilizing non-bone-patellar tendon-bone autografts\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",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":86,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"Rothman Orthopaedic Institute","Philadelphia","Pennsylvania","19107","United States",{"lat":92,"lon":93},39.95238,-75.16362,[],[],[97],{"pmid":98,"type":99,"citation":100},"41522461","DERIVED","Johns WL, Voskeridjian A, Miltenberg B, Muchintala R, Dodson CC, Cohen SB, Salvo J, Sherman M, Ciccotti MG, Hammoud S. Regional Anesthesia Utilizing Liposomal Bupivacaine, With or Without Dexamethasone, Provides Excellent Pain Control and Minimizes Opioid Consumption Following Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2026 Jan 8;14(1):23259671251401596. doi: 10.1177\u002F23259671251401596. eCollection 2026 Jan.",[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Rupture of anterior cruciate ligament",[],{"nct_id":4,"found":107,"summary":15,"prompt_version":15},false]