Comparison of Analgesic Efficacy and Impact on Motor Function in Knee Replacement Surgery: 0.1% Naropeine Tri-block Versus 0.5% Naropeine iPACK Saphenous Block - A Prospective Randomised Trial (ProBlocs)
Over the last two decades, perioperative analgesia has evolved. Spinal and epidural anaesthesia, once common, have been gradually phased out due to their side effects. The femoral block combined with the sciatic block, possibly with a perineural catheter, is now the gold standard for ensuring prolonged, high-quality analgesia. However, these blocks can cause muscle weakness in the quadriceps, limiting patients' functional recovery.
To optimise functional rehabilitation, recent techniques favour more distal and selective blocks, such as the adductor canal (saphenous) block and the iPACK, which allow effective anaesthesia to be maintained whilst preserving motor function. However, these blocks do not always guarantee complete analgesia and may require additional blocks.
The hypothesis of the current study is based on the idea that a proximal block targeting the femoral, obturator and sciatic nerves, administered with a low concentration of naropeine (0.1%), could provide more effective analgesia than a 0.5% saphenous iPACK block, whilst preserving motor function The originality of our approach in the current study lies in the use of dissociative proximal blocks performed with low concentrations of local anaesthetics, aimed at effectively covering the innervation of the knee whilst preserving motor function.
The expected outcomes of this research are to optimise analgesic management for patients undergoing functional orthopaedic knee surgery, to promote early postoperative walking rehabilitation, to reduce the risk of chronic pain following knee arthroplasty, and to provide evidence to guide anaesthetic and post-surgical rehabilitation practices
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Dr Emilie ELLIES DROUAUD
- 电话号码:+33 (0)679324918
- 邮箱:elliese64@gmail.com
学习地点
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Paris、法国、75016
- Clinique Jouvenet
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接触:
- Dr Emilie ELLIES DROUAUD
- 电话号码:+33 (0)679324918
- 邮箱:elliese64@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age > 18 years;
- Patients scheduled for total knee replacement (TKR);
- ASA (American Society of Anesthesiologists) class 1 to 3;
- Patient who is able to understand the information relating to the study, read the information leaflet and agree to sign the informed consent form;
- Enrolment iin the French healthcare system.
Exclusion Criteria:
- Patients with an ASA score > 3;
- Patients with a chronic pain condition requiring regular prescription pain relief, such as osteoarthritis, fibromyalgia, neuropathic pain or rheumatoid arthritis;
- Patients with a major anxiety disorder (APAIS score);
- Patients with a history of algodystrophy;
- Pregnant or breastfeeding women;
- History or evidence of any other clinically significant disorder, condition or disease which, in the investigator's opinion, would pose a risk to patient safety or interfere with the assessment, procedures or completion of the study;
- Participation in any other clinical trial during the duration of the study;
- Patients under guardianship or curatorship or subject to deprivation of liberty.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Experimental group (tri-block)
Anaesthesia of femoral block, obturator block and popliteal sciatic block performed using 0.1% naropeine, combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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Injection of 0.1% naropeine for a femoral, obturator and sciatic block (Tri-block technique), combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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有源比较器:Control Group (iPACK saphène)
Anaesthesia of iPACK block and saphenous block performed using 0.5% naropine, also combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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Injection of 0.5% naropeine for an iPACK and saphenous nerve block (iPACK saphenous arm), combined with intraoperative intravenous administration of 0.15 mg/kg of dexamethasone.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Total morphine consumption in the postoperative period at 72 hours during the hospital stay
大体时间:from knee surgery (enrollment) to 3 days post-surgery
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from knee surgery (enrollment) to 3 days post-surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- COS-RGDS-2024-12-033
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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