Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety (SQUARE)
研究概览
详细说明
A sample size of 100 patients (50 per group) was calculated based on 20% reduction in morphine consumption with 0.05% significance and a power of 0.8.
After ethical committee approval, eligible patients scheduled to have a fast-track total hip arthroplasty are screened during preoperative evaluation clinic. Informed written consent will be obtained from all patients during pre-anesthesia visit the day before surgery (J-1). Consenting patients will be randomized the day of surgery (J0) to undergo QLB with ropivacaine ("ropivacaine group") or normal saline ("saline group").
Before general anesthesia, all patients will have a needle-insertion posterior to the quadratus lumborum muscle avec injection of either ropivacaine in the "ropivacaine group" or normal saline in the "saline group".
After general anesthesia induction, dexamethasone and ketamine will be given to all patients.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Occitanie
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Montpellier、Occitanie、法国、34934
- Lapeyronie Teaching Hospital Montpellier
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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
描述
Inclusion Criteria:
- American Society of Anesthesiologists Physical Classification Status (ASA) I to III
- Age ≥ 18 years
- Scheduled for fast-track total hip arthroplasty
- Written informed consent
- Patient covered by health insurance Exclusion Criteria
- Protected patients or patients incapable of giving written informed consent
- Pregnant or breastfeeding woman
- Vulnerable adult
- Contraindication for fast-track surgery
- Inability to comprehend or participate in pain scoring scales
- Allergy to study drugs
- Severe coagulopathy
- Chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min (estimated by the Cockcroft & Gault formula)
- Chronic pain (treated by nonsteroidal anti-inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
- Peripheral neuropathy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：ropivacaine
Active Comparator: ropivacaine group - Before general anaesthesia, ultrasound guided Quadratus Lumborum Block (QLB) will be performed with 30 mL 0.33% Ropivacaine |
Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block
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安慰剂比较：placebo
Sham Comparator: saline group - Before general anaesthesia, ultrasound guided Sham Quadratus Lumborum Block (QLB) will be performed with 30 mL saline. |
Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block
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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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Efficacy of the posterior quadratus lumborum block (QLB) versus placebo on morphine consumption during the first 24 hours after a total hip arthroplasty
大体时间：the first 24 hours after a total hip arthroplasty
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the first 24 hours after a total hip arthroplasty
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合作者和调查者
调查人员
- 首席研究员：Philippe BIBOULET, MD、University Hospital, Montpellier
研究记录日期
研究主要日期
学习开始 (实际的)
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 (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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
posterior Quadratus Lumborum Block (QLB)的临床试验
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Namik Kemal University完全的腹股沟疝 | Quadratus Lumborum 块 | 腹横肌平面 (TAP) 阻滞 | 髂腹下/髂腹股沟神经阻滞火鸡
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Federal University of São PauloIrmandade da Santa Casa de Misericordia de Sao Paulo未知