Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Patients Undergoing Amputation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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/kg (ideal body weight) over 10 minutes, followed by a continuous infusion at 1.5 mg/kg/hour 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Exclusion Criteria:
- •1. Body weight < 40 kg or > 100 kg；
- •Cardiac conduction defects (second- or third-degree atrioventricular block) or cardiac insufficiency (left ventricular ejection fraction [LVEF] < 50%)；
- •Severe hepatic impairment (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or bilirubin levels > 2.5 times the upper limit of normal)
- •Renal insufficiency (creatinine clearance [CrCl] < 60 mL/min)；
- •Known allergy to the study drug；
- •Chronic opioid abuse；
- •Patients unable to communicate verbally.
研究组 & 干预措施
placebo group
An equivalent volume of normal saline is administered during anesthesia and via the intravenous patient-controlled analgesia (PCA) pump postoperatively.
干预措施: 0.9% normal saline (Drug)
Lidocaine group
During anesthesia induction, intravenous lidocaine is administered at a dose of 1.5 mg/kg (based on ideal body weight) over 10 minutes. This is followed by a continuous infusion at 1.5 mg/kg/h until the end of surgery, and subsequently by a lidocaine-containing intravenous patient-controlled analgesia pump for postoperative pain management.
干预措施: Lidocaine Hydrochloride, Injectable (Drug)
结局指标
主要结局
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
时间窗: The first 24 hours after surgery
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
次要结局
- 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.(At 48 and 72 hours postoperatively, and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier)
- 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.)
- Incidence of phantom limb pain during hospitalization(Duration of hospital stay, an expected average of 7 days)
- 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.(At 24, 48 and 72 hours postoperatively，and on postoperative day (POD) 7 or the day before discharge, whichever occurred earlier.)
- The incidence of PONV during the first 24 hours after surgery(At 24 hours after surgery])
- Recovery quality at 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier.(At 24, 48, and 72 hours postoperatively, as well as on postoperative day 7 or the day before discharge，whichever occurred earlier.)
- Bowel function recovery(Duration of hospital stay, an expected average of 7 days)
- Incidence of residual limb pain and phantom limb pain at 6 months and 1 year postoperatively(At 6 months and 1 year postoperatively)
- Quality of life at 6 months and 1 year postoperatively(At 6 months and 1 year postoperatively)
- Sleep quality at 6 months and 1 year postoperatively(At 6 months and 1 year postoperatively)
研究者
Chunling Jiang
West China Hospital, Sichuan University
West China Hospital