Blood Levels of Local Anaesthetic in Knee Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma levels of ropivacaine
研究概览
简要总结
The primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee replacement surgery. The investigators plan to measure these levels by testing blood samples taken over a timed period.
This will allow us to confirm whether the current regimen of local anaesthetic use is within safe limits.
详细描述
Local anaesthetic (LA) toxicity may occur when the blood levels of a drug become particularly high. There is a need to confirm that the technique is safe to use. In addition, journal case reports may only describe serious side-effects of toxicity such as abnormal heart rhythms whilst more subtle clinical signs are rarely reported.
The investigators would like to study whether or not toxic levels may be approached in some patients or whether more subtle toxicity symptoms and signs are missed. For example, irregular heartbeat, low blood pressure or confusion/agitation.
Therefore, the investigators intend to study ropivacaine blood levels in patients receiving a total knee replacement in the Golden Jubilee National Hospital. A series of timed samples will be taken during the perioperative period. The anaesthesia and surgery will be performed as routine and no new treatment will be involved. Patient demographics, ropivacaine blood levels and clinical observations following LA administration will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients greater than 65 years of age
排除标准
- •Patients with a known sensitivity/allergy to ropivacaine or amide-type local anaesthetics
- •Patients who are not suitable for the Caledonian technique
- •Patients who refuse or are unable to give consent
- •Patients undergoing bilateral hip replacements
- •Patients with known heart, liver or kidney failure
研究组 & 干预措施
Ropivacaine
Injection of local anaesthetic (ropivacaine) into the knee joint following knee arthroplasty. Total dose 200mls of 0.2% ropivacaine or 400mg at the time of surgery plus up to 5 top-up boluses (40mls of 0.2% ropivacaine or 80mg) postoperatively.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Plasma levels of ropivacaine
时间窗: First 24 hours after surgery
Plasma levels of ropivacaine were analysed to determine total and free levels
次要结局
- Evidence of dysrrhythmias as measured by 24-hour Holter monitoring(First 24 hours after surgery)
- Clinical observations(First 24 hours after surgery)