[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653271":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":62,"studyPopulation":50,"armGroups":63,"interventions":76,"overallOfficials":50,"centralContacts":88,"locations":94,"responsibleParty":112,"collaborators":50,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":50,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":50,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":50,"overallStatus":134,"whyStopped":50,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"West China Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"The primary outcome is the incidence of moderate-to-severe (NRS ≥4) movement-evoked pain (by turning over or moving the residual limb) at 24 h postoperatively","The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain","The first 24 hours after surgery",[14,18,21,25,29,33,37,40,44,47],{"measure":15,"description":16,"timeFrame":17},"Incidence of moderate-to-severe movement-evoked pain, assessed at 48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.","The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.","At 48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier",{"measure":19,"description":16,"timeFrame":20},"The incidence of moderate to severe pain at rest ，assessed at 24、48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.","At 24、48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.",{"measure":22,"description":23,"timeFrame":24},"Incidence of phantom limb pain during hospitalization","Phantom limb pain refers to painful sensations perceived in the absent limb, typically involving the distal portion, and may be described as burning, stabbing, throbbing, or cramping. Pain intensity at rest and during activity (e.g., turning over or moving the residual limb) is assessed using an 11-point Numerical Rating Scale (NRS; 0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Neuropathic pain components are screened using the ID Pain tool, and the corresponding score is recorded.","Duration of hospital stay, an expected average of 7 days",{"measure":26,"description":27,"timeFrame":28},"The cumulative morphine consumption at 24, 48 and 72 hours postoperatively，and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.","Intraoperative and postoperative opioids use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator","At 24, 48 and 72 hours postoperatively，and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.",{"measure":30,"description":31,"timeFrame":32},"The incidence of PONV during the first 24 hours after surgery","we considered it PONV if patients felt any nausea or had any vomiting","At 24 hours after surgery]",{"measure":34,"description":35,"timeFrame":36},"Recovery quality at 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier.","Quality of Recovery-15 (QoR-15) scores","At 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier.",{"measure":38,"description":39,"timeFrame":24},"Bowel function recovery","defined as the time to first defecation or time to first flatus",{"measure":41,"description":42,"timeFrame":43},"Incidence of residual limb pain and phantom limb pain at 6 months and 1 year postoperatively","Residual limb pain is localized to the surgical site and is predominantly nociceptive, often described as sharp. Phantom limb pain refers to painful sensations perceived in the absent limb, typically involving the distal portion, and may be described as burning, stabbing, throbbing, or cramping. For both types, the location and severity are documented. Pain intensity at rest and during activity (e.g., turning over or moving the residual limb) is assessed using an 11-point Numerical Rating Scale (NRS; 0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Neuropathic pain components are screened using the ID Pain tool, and the corresponding score is recorded.","At 6 months and 1 year postoperatively",{"measure":45,"description":46,"timeFrame":43},"Quality of life at 6 months and 1 year postoperatively","Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score",{"measure":48,"description":49,"timeFrame":43},"Sleep quality at 6 months and 1 year postoperatively","Assessed using the Pittsburgh Sleep Quality Index (PSQI)",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":57},"QUADRUPLE",[58,59,60,61],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Patients who meet the inclusion criteria are randomly allocated in a 1:1 ratio to the lidocaine or placebo group. Following induction of general anesthesia, the lidocaine group receives an intravenous bolus of 1.5 mg\u002Fkg (ideal body weight) over 10 minutes, followed by a continuous infusion at 1.5 mg\u002Fkg\u002Fhour until the end of surgery. The placebo group receives a matching volume of normal saline during the same period. For postoperative analgesia, the lidocaine group is provided with a lidocaine-containing intravenous patient-controlled analgesia (PCA) pump, and the placebo group receives a standard PCA pump.",[64,70],{"label":65,"type":66,"description":67,"interventionNames":68},"Lidocaine group","EXPERIMENTAL","During anesthesia induction, intravenous lidocaine is administered at a dose of 1.5 mg\u002Fkg (based on ideal body weight) over 10 minutes. This is followed by a continuous infusion at 1.5 mg\u002Fkg\u002Fh until the end of surgery, and subsequently by a lidocaine-containing intravenous patient-controlled analgesia pump for postoperative pain management.",[69],"Drug: Lidocaine Hydrochloride, Injectable",{"label":71,"type":72,"description":73,"interventionNames":74},"placebo group","PLACEBO_COMPARATOR","An equivalent volume of normal saline is administered during anesthesia and via the intravenous patient-controlled analgesia (PCA) pump postoperatively.",[75],"Drug: 0.9% normal saline",[77,83],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","Lidocaine Hydrochloride, Injectable","During anesthesia induction, intravenous lidocaine is administered at a dose of 1.5 mg\u002Fkg (based on ideal body weight) over 10 minutes. This is followed by a continuous infusion at 1.5 mg\u002Fkg\u002Fh until the end of surgery. Postoperative pain management involves the use of a patient-controlled intravenous analgesia (PCIA) device, which contains lidocaine 50 mg\u002Fkg (calculated based on ideal body weight, not exceeding 3500 mg), sufentanil 3 μg\u002Fkg (calculated based on ideal body weight for obese patients), and granisetron 12 mg, diluted to a total volume of 200 mL with 0.9% normal saline.",[65],[65],{"type":78,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"0.9% normal saline","In the placebo group, the same volume of normal saline is administered during anesthesia. The postoperative PCIA device contains sufentanil 3 μg\u002Fkg (calculated based on ideal body weight for obese patients) and granisetron 12 mg, diluted to a total volume of 200 mL with 0.9% normal saline.",[71],[71],[89],{"name":90,"role":91,"phone":92,"phoneExt":50,"email":93},"Chunling Jiang,, PhD","CONTACT","18980601096","jiangchunling@scu.edu.cn",[95],{"facility":96,"status":50,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041","China","CN",{"type":103,"coordinates":104},"Point",[105,106],104.06667,30.66667,{"lat":106,"lon":105},[109],{"name":110,"role":91,"phone":111,"phoneExt":50,"email":93},"Fengming Luo, PhD","02885423593",{"type":113,"investigatorFullName":114,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Chunling Jiang","100653271","the-effect-of-perioperative-intravenous-lidocaine-infusion-on-post-amputation-pain-in-amputee-patients-100653271",false,"NCT07783867","The Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Amputee Patients","Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Patients Undergoing Amputation","Inclusion Criteria:\n\n* 1.Age 18-80 years; 2.Patients scheduled for elective or emergency primary above or below knee amputation (AKA or BKA) under general anesthesia; 3.American Society of Anesthesiologists (ASA) physical status I-III. The exclusion criteria.\n\nExclusion Criteria:\n\n* 1\\. Body weight \\\u003C 40 kg or \\> 100 kg； 2. Cardiac conduction defects (second- or third-degree atrioventricular block) or cardiac insufficiency (left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%)； 3. Severe hepatic impairment (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], or bilirubin levels \\> 2.5 times the upper limit of normal) 4. Renal insufficiency (creatinine clearance \\[CrCl\\] \\\u003C 60 mL\u002Fmin)； 5. Known allergy to the study drug； 6. Chronic opioid abuse； 7. Patients unable to communicate verbally.","ALL","18 Years","80 Years",{"count":126,"type":127},200,"ESTIMATED","INTERVENTIONAL",[130],"NA","This study aimes to evaluate whether perioperative intravenous lidocaine infusion effectively relieves postoperative pain, enhances recovery, and reduces chronic stump and phantom limb pain after amputation, thereby informing future multicenter trials and clinical guideline development.",[133],"Amputation","NOT_YET_RECRUITING","2026-08-23",{"date":137,"type":138},"2026-08-25","ACTUAL",{"date":140,"type":127},"2026-10-01",{"date":142,"type":127},"2029-12-30",{"name":5,"class":6},1]