Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Frequency of unplanned analgesia interventions.
研究概览
简要总结
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.
详细描述
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted for unilateral primary total knee arthroplasty.
排除标准
- •ASA score > 3
- •BMI > 40
- •refusal of loco-regional technique.
- •psychiatric disease.
- •inability to understand/ use the Local anesthetic delivery pump.
- •local anesthetic allergy,
- •porphyry,
- •uncontrolled epilepsy,
- •severe cardiac arrhythmia.
研究组 & 干预措施
Continous infusion ropivacaine
Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ...
干预措施: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) (Drug)
PIB ropivacaine
Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ...
干预措施: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) (Drug)
结局指标
主要结局
Frequency of unplanned analgesia interventions.
时间窗: up to 72 hours after surgery
Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period.
次要结局
- Pain difference(up to 72 hours after surgery)
- Motor block frequency(up to 72 hours after surgery)
- Mobilization quality during physiotherapy sessions.(up to 72 hours after surgery)
- local anesthesia technique related complications(until catheter removal 48 hours after surgery)
研究者
J P Lecoq
MD
University of Liege