[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588537":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adductor Canal Block","EXPERIMENTAL","Phase I: The Bayesian Optimal Interval (BOIN) design is adopted to evaluate the volume escalation of liposomal bupivacaine (10, 15, 20, 25, 30, 35, 40 mL). There are 3 cases in each group, with an initial volume of 20 mL (referring to previous ACB studies d). The target incidence of adverse events (quadriceps femoris muscle strength decline ≥ 25%) is set at 10%, and the maximum volume is limited to 40 mL to avoid local anesthetic toxicity.\n\nPhase II: Cohort expansion is carried out at volume levels lower than the MTV. The Bayesian Optimal Phase II (BOP2) design is adopted, with each group expanded to 12 cases to evaluate the balance point between block success rate and motor function preservation.",[13],"Drug: Perform adductor canal block with liposomal bupivacaine.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Perform adductor canal block with liposomal bupivacaine.","Patient Positioning: Supine with the surgical limb slightly flexed and externally rotated.\n\nOperator Setup: The operator stands on the surgical side, with the ultrasound machine positioned contralaterally. The anterior thigh is sterilized and draped.\n\nUltrasound Technique: A high-frequency (5-12 MHz) linear ultrasound probe (Sonosite M-Turbo), protected by a 3M Tegaderm dressing, is placed perpendicular to the skin at the midpoint between the femoral trochanter and the superior patellar margin. The probe is maneuvered to visualize the adductor canal structures.\n\nNeedle Insertion: After local anesthesia at the insertion site, a 22G 80 mm needle is advanced using an in-plane technique until the tip reaches the triangular hypoechoic area lateral to the femoral artery. Following negative aspiration for blood, 1.33% liposomal bupivacaine is injected around the target site.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Hongwei Shi","The First Affiliated Hospital with Nanjing Medical University","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Liu Han","CONTACT","18951670163","han_cold.student@sina.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Nanjing First Hospital","RECRUITING","Nanjing","Jiangsu","210006","China","CN",{"type":42,"coordinates":43},"Point",[44,45],118.77778,32.06167,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":20,"email":51},"Jie Wei","18752113232","961683175@qq.com",{"type":25,"investigatorFullName":23,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Director, Department of Anesthesia, Pain and Perioperative Medicine","100588537","phase-4-determination-of-the-optimal-volume-of-liposomal-bupivacaine-in-adductor-canal-block-for-knee-joint-surgery-100588537",false,"NCT06942689","Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery","Determination of the Optimal Volume of Liposomal Bupivacaine in Single-Shot Adductor Canal Block for Knee Joint Surgery-A Phase I\u002FII Trial","Inclusion Criteria:\n\n* Patients undergoing elective general anesthesia for unilateral knee joint surgery.\n* Patients who provide informed consent.\n* Aged between 18 and 65 years old, regardless of gender.\n* American Society of Anesthesiologists (ASA) physical status classification of Ⅰ to Ⅲ\n* Body mass index (BMI) ≤ 35 kg\u002Fm².\n\nExclusion Criteria:\n\n* Femoral neuropathy.\n* Coagulation dysfunction.\n* Allergy to local anesthetics.\n* Infection at the puncture site.\n* History of chronic pain or opioid use.\n* Pregnancy.\n* Diabetes mellitus and peripheral neuropathy.","ALL","18 Years","85 Years",{"count":65,"type":66},63,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","Building on Bayesian design methodologies from volume optimization studies of ropivacaine in shoulder surgery, this study pioneers the application of a seamless dose-finding strategy in knee ACB. Utilizing advanced statistical models (BOIN\u002FBOP2 design), we aim to systematically evaluate the volume-effect relationship of liposomal bupivacaine, providing precise dosing recommendations to advance personalized and optimized analgesic protocols for knee surgery.",[72],"Optimal Volume of Liposomal Bupivacaine",[74,9,75,76,77],"Liposomal Bupivacaine","Knee Surgery","Maximum Tolerated Volume","Quadriceps Muscle Strength","2025-08-31",{"date":80,"type":81},"2025-09-08","ACTUAL",{"date":83,"type":81},"2025-06-01",{"date":85,"type":66},"2027-12-31",{"name":5,"class":6},1]