Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Morphine consumption
研究概览
简要总结
40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status according to American Society of Anesthesiologists (ASA) I-III
- •Patients scheduled for total knee arthroplasty
排除标准
- •Contraindication for central and/or peripheral nervous blockade
- •Reoperation on previous total knee arthroplasty
- •History of allergic or other adverse reactions on the agents used in the study
- •Chronic opioid or gabapentinoid use
- •Serious psychiatric, mental and cognitive disorders
- •Language barrier
- •Difficulty in understanding or using a patient controlled analgesia device
研究组 & 干预措施
LIA
Local infiltration analgesia
干预措施: Ropivacaine (Drug)
sham LIA
Saline injections
干预措施: Saline (Other)
结局指标
主要结局
Morphine consumption
时间窗: 24 hours
次要结局
- Duration of hospitalization(1 month)
- NRS scores(24 hours)
- Complications(24 hours)
- Patient satisfaction(24 hours)
研究者
Alexandros Makris
Consultant Anaesthesiologist
Asklepieion Voulas General Hospital