[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576029":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":41,"centralContacts":60,"locations":66,"responsibleParty":84,"collaborators":41,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":41,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":41,"enrollmentInfo":97,"targetDuration":41,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":41,"overallStatus":106,"whyStopped":41,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Inner Mongolia Baogang Hospital","OTHER",[8,15,20,25,31],{"label":9,"type":10,"description":11,"interventionNames":12},"FNB Group","EXPERIMENTAL","In the femoral nerve block (FNB) group, the femoral nerve was blocked distal to the inguinal ligament and lateral to the femoral artery. Under sterile conditions and ultrasound guidance using a short-axis out-of-plane approach, a 22-gauge insulated needle was advanced adjacent to the femoral nerve. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL\u002Fhr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg\u002Fkg, followed by a continuous infusion of 0.1-0.3 mg\u002Fkg\u002Fhr.",[13,14],"Device: Femoral Nerve Block","Device: General Aneasthesia",{"label":16,"type":10,"description":17,"interventionNames":18},"CS-FNB Group","In the combined sciatic and femoral nerve block (CS-FNB) group, the femoral nerve block was performed as described above. The sciatic nerve block was performed at either the gluteal region or popliteal fossa. Under sterile conditions and ultrasound guidance using either an in-plane or out-of-plane approach, a 22-gauge insulated needle was advanced adjacent to the sciatic nerve. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL\u002Fhr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg\u002Fkg, followed by a continuous infusion of 0.1-0.3 mg\u002Fkg\u002Fhr.",[19,14],"Device: Combined Sciatic and Femoral Nerve Block",{"label":21,"type":10,"description":22,"interventionNames":23},"LPB Group","In the lumbar plexus block (LPB) group, the lumbar plexus was blocked paraspinally within the psoas muscle. Under sterile conditions, ultrasound guidance, or with the assistance of a nerve stimulator, using either an in-plane or out-of-plane approach, a 22-gauge insulated needle was advanced within the psoas muscle adjacent to the lumbar plexus. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL\u002Fhr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg\u002Fkg, followed by a continuous infusion of 0.1-0.3 mg\u002Fkg\u002Fhr.",[24,14],"Device: Lumbar plexus block",{"label":26,"type":27,"description":28,"interventionNames":29},"EA group","ACTIVE_COMPARATOR","For epidural analgesia, an initial bolus of 5-15 mL of 0.5% ropivacaine was administered followed by a continuous infusion of 0.2% ropivacaine at a rate of 3-10 mL\u002Fhr. For pediatric patients, an initial bolus of 0.2% ropivacaine at 0.5-1 mg\u002Fkg was administered, not exceeding a maximum total dose of 2-2.5 mg\u002Fkg, followed by a continuous infusion of 0.1-0.3 mg\u002Fkg\u002Fhr.",[30],"Procedure: Epidural Analgesia",{"label":32,"type":10,"description":33,"interventionNames":34},"PCA group","For intravenous patient-controlled analgesia (PCA), fentanyl was administered at a dose of 2 mcg\u002Fkg, diluted in 100 mL of normal saline. The basal infusion rate was set at 2 mL\u002Fhr, with a PCA dose of 2 mL and a lockout interval of 15 minutes.",[35,14],"Drug: Intravenous patient-controlled analgesia",[37,42,45,48,52,56],{"type":38,"name":39,"description":11,"armGroupLabels":40,"otherNames":41},"DEVICE","Femoral Nerve Block",[9],null,{"type":38,"name":43,"description":17,"armGroupLabels":44,"otherNames":41},"Combined Sciatic and Femoral Nerve Block",[16],{"type":38,"name":46,"description":22,"armGroupLabels":47,"otherNames":41},"Lumbar plexus block",[21],{"type":49,"name":50,"description":28,"armGroupLabels":51,"otherNames":41},"PROCEDURE","Epidural Analgesia",[26],{"type":53,"name":54,"description":33,"armGroupLabels":55,"otherNames":41},"DRUG","Intravenous patient-controlled analgesia",[32],{"type":38,"name":57,"description":58,"armGroupLabels":59,"otherNames":41},"General Aneasthesia","Following administration of the regional anesthesia, general anesthesia with endotracheal intubation will be performed. 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%.",[16,9,21,32],[61],{"name":62,"role":63,"phone":64,"phoneExt":41,"email":65},"Xiaguang Duan, Master's degree","CONTACT","+86 13314720012","alonlord2023@gmail.com",[67],{"facility":5,"status":41,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Baotou","Inner Mongolia","014010","China","CN",{"type":74,"coordinates":75},"Point",[76,77],109.84389,40.6516,{"lat":77,"lon":76},[80],{"name":81,"role":63,"phone":82,"phoneExt":41,"email":83},"Xiangyu Wang, Master's degree","+86 0472 5992830","KevinDuan0901@gmail.com",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Xiaguang Duan","Deputy Chief of Anesthesiology","100576029","multimodal-analgesia-versus-peripheral-nerve-block-for-postoperative-pain-management-after-lower-limb-injury-surgery-100576029",false,"NCT06779968","Multimodal Analgesia Versus Peripheral Nerve Block for Postoperative Pain Management After Lower Limb Injury Surgery","Multimodal Analgesia Versus Peripheral Nerve Block for Postoperative Pain Management After Lower Limb Injury Surgery: a Randomized Controlled Trial","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status classification I-III\n* Patients (or their guardians) voluntarily participate in this study and sign a written informed consent form\n* Patients (or their guardians) are able to understand the study content and cooperate with the study protocol\n\nExclusion Criteria:\n\n* Known allergy to local anesthetics or opioid analgesics.\n* Presence of contraindications to local or epidural anesthesia.\n* Presence of undiagnosed or poorly characterized neuropathic pain.\n* Presence of severe mental illness that would impede the participant's ability to cooperate with study assessment and treatment procedures.\n* Clinically significant coagulopathy or current use of anticoagulant medications.\n* Presence of infection at the planned puncture site or systemic infection.\n* Pregnancy or lactation.","ALL","2 Years",{"count":98,"type":99},150,"ESTIMATED","INTERVENTIONAL",[102],"NA","The purpose of this clinical trial is to understand the effectiveness of femoral nerve block, combined sciatic and femoral nerve block, lumbar plexus block, epidural block, and intravenous analgesia pump in the application of lower limb injury (total knee replacement, knee arthroscopy, patella fracture, femoral shaft fracture) surgery. It will also understand the safety of the drugs liposomal bupivacaine and ropivacaine. The main question it aims to answer is: Does nerve block reduce the number of times participants need to use analgesics postoperatively? The researchers will compare femoral nerve block, combined sciatic and femoral nerve block, lumbar plexus block, epidural block, and intravenous analgesia pump to see which analgesic method has the best postoperative analgesic effect. Participants will: undergo nerve block first, then endotracheal intubation general anesthesia after entering the operating room; record vital signs during surgery, record postoperative analgesic doses, NRS pain scores, patient satisfaction, and postoperative nausea and vomiting.",[105],"Lower Limb Injury","NOT_YET_RECRUITING","2025-01-14",{"date":109,"type":110},"2025-01-17","ACTUAL",{"date":112,"type":99},"2025-01-20",{"date":114,"type":99},"2025-05-10",{"name":86,"class":6},1]