[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576004":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Inner Mongolia Baogang Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GA group","EXPERIMENTAL","General anesthesia group. Anesthesia induction will be achieved using propofol (1.5-2 mg\u002Fkg i.v.), rocuronium (1-2 mg\u002Fkg i.v.), and fentanyl (1-2 μg\u002Fkg i.v.). Anesthesia will be maintained using sevoflurane or desflurane, with inhaled concentration adjusted based on Bispectral Index (BIS) monitoring. A continuous infusion of remifentanil (0.05-0.2 μg\u002Fkg\u002Fmin) will be administered, with adjustments to maintain blood pressure and heart rate within ±20% of baseline values. Following induction, patients will be mechanically ventilated in pressure-regulated volume control (PRVC) mode. The ventilator (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) settings will be: tidal volume 6-8 mL\u002Fkg, positive end-expiratory pressure 0 cm H2O, inspiratory to expiratory ratio 1:2, respiratory rate 16 breaths per minute (BPM), and fraction of inspired oxygen 41%.",[13],"Device: General Anesthesia (GA)",{"label":15,"type":10,"description":16,"interventionNames":17},"CBPB group","Patients were positioned supine with the head slightly turned to the contralateral side to expose the supraclavicular fossa. The injection site was prepared using standard aseptic techniques. Under ultrasound guidance, a needle was advanced to the vicinity of the brachial plexus. Aspiration was performed to confirm the absence of blood return before the slow, incremental injection of either liposomal bupivacaine \\[adult dose: 133 mg (10 mL) to 266 mg (20 mL)\\] or ropivacaine \\[adult dose: 20 mL of 0.5% ropivacaine, administered via continuous infusion at a rate of 5-10 mL\u002Fh; pediatric dose: 0.1% ropivacaine at 0.1-0.2 mL\u002Fkg, administered via continuous infusion at 0.05-0.15 mL\u002Fkg\u002Fh\\]. Patient responses were closely monitored throughout the procedure.",[13,18],"Device: Continuous Brachial Plexus Block",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","General Anesthesia (GA)","Anesthesia induction will be achieved using propofol (1.5-2 mg\u002Fkg i.v.), rocuronium (1-2 mg\u002Fkg i.v.), and fentanyl (1-2 μg\u002Fkg i.v.). Anesthesia will be maintained using sevoflurane or desflurane, with inhaled concentration adjusted based on Bispectral Index (BIS) monitoring. A continuous infusion of remifentanil (0.05-0.2 μg\u002Fkg\u002Fmin) will be administered, with adjustments to maintain blood pressure and heart rate within ±20% of baseline values. Following induction, patients will be mechanically ventilated in pressure-regulated volume control (PRVC) mode. The ventilator (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) settings will be: tidal volume 6-8 mL\u002Fkg, positive end-expiratory pressure 0 cm H2O, inspiratory to expiratory ratio 1:2, respiratory rate 16 breaths per minute (BPM), and fraction of inspired oxygen 41%.",[15,9],null,{"type":21,"name":27,"description":16,"armGroupLabels":28,"otherNames":25},"Continuous Brachial Plexus Block",[15],[30],{"name":31,"affiliation":5,"role":32},"Xiangyu Wang, MM","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Xiaguang Duan, Master's degree","CONTACT","+86 13314720012","alonlord2023@gmail.com",[40],{"facility":5,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Baotou","Inner Mongolia","014010","China","CN",{"type":47,"coordinates":48},"Point",[49,50],109.84389,40.6516,{"lat":50,"lon":49},[53,57],{"name":54,"role":36,"phone":55,"phoneExt":25,"email":56},"Xiangyu Wang, Master's degree","+86 0472 5992830","KevinDuan0901@gmail.com",{"name":31,"role":36,"phone":25,"phoneExt":25,"email":25},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Xiaguang Duan","Deputy Chief of Anesthesiology","100576004","efficacy-and-safety-of-liposomal-bupivacaine-and-ropivacaine-in-upper-limb-surgery-100576004",false,"NCT06779643","Efficacy and Safety of Liposomal Bupivacaine and Ropivacaine in Upper Limb Surgery","Efficacy and Safety of Liposomal Bupivacaine and Ropivacaine in Upper Limb Surgery: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age: Two years or older.\n* ASA Physical Status: American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.\n* Surgical Indication: Patients requiring surgical treatment for any of the following upper limb injuries: Burn injuries. Digital replantation. Upper limb fractures, including fractures of the radius, ulna, humerus, and carpal bones. Hand fractures, including fractures of the phalanges and metacarpals.\n* Patients scheduled to undergo either a continuous brachial plexus block combined with general anesthesia or general anesthesia alone.\n* Patients (or their legal guardians) provided voluntary written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to local anesthetic agents.\n* Presence of infection or skin disease at the planned puncture site.\n* Severe coagulation disorders or current use of anticoagulant medications that cannot be safely discontinued for the procedure.\n* Presence of severe cardiopulmonary or neurological disease.\n* Inability to cooperate with regional or general anesthesia.\n* Pregnancy or lactation.\n* Presence of severe psychiatric illness or cognitive impairment that would hinder participation.\n* Long-term use of analgesic medications.","ALL","2 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","This clinical trial aims to evaluate the efficacy and safety of liposomal bupivacaine and ropivacaine when used in different brachial plexus blocks and epidural anesthesia for the management of pain associated with burn injuries, digital replantation, and upper limb fractures (including radial, ulnar, humeral, and carpal fractures), as well as hand fractures (including phalangeal and metacarpal fractures). The primary objective is to determine whether liposomal bupivacaine or ropivacaine reduces the required postoperative analgesic dosage in these patient populations.\n\nSpecifically, this study will compare brachial plexus blockade with either liposomal bupivacaine or ropivacaine, combined with general anesthesia, against general anesthesia alone to assess the effectiveness of these two local anesthetics in achieving postoperative analgesia.\n\nEnrolled participants will be randomized to one of two treatment arms: either brachial plexus block followed by endotracheal intubation and general anesthesia or general anesthesia alone. Postoperative vital signs, analgesic requirements, and recovery parameters will be continuously monitored and recorded.",[79],"Upper Limb Injury","NOT_YET_RECRUITING","2025-01-13",{"date":83,"type":84},"2025-01-16","ACTUAL",{"date":86,"type":73},"2025-02-01",{"date":88,"type":73},"2025-05-10",{"name":60,"class":6},1]