Blood Levels of Local Anaesthetic in Hip Arthroplasty (BLAST)
Blood Levels of Local Anaesthetic in Hip Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Hip Arthroplasty
The primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total hip 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.
研究概览
详细说明
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 hip 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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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West Dunbartonshire
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Clydebank、West Dunbartonshire、英国、G81 4dy
- Golden Jubilee National Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male or female patients greater than 65 years of age
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Ropivacaine
Injection of local anaesthetic (ropivacaine) into the hip joint following hip arthroplasty.
Total dose 180mls of 0.2% ropivacaine or 360mg at the time of surgery.
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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罗哌卡因的血浆水平
大体时间：术后第一个 24 小时
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分析罗哌卡因的血浆水平以确定总水平和游离水平
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术后第一个 24 小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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临床观察
大体时间：术后第一个 24 小时
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在采血的同时记录临床观察结果，包括局部麻醉剂毒性的潜在症状和体征
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术后第一个 24 小时
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Holter monitoring
大体时间：First 24 hours after surgery
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24-hour Holter monitoring was conducted to detect any potential sequelae of local anaesthetic toxicity
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First 24 hours after surgery
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合作者和调查者
调查人员
- 首席研究员：Michael Gill, MBChB、NHS Research Scotland
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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