Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.
Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.
all patients with a first anterior arthroplasty, give their informed consent to be randomized to control or study protocol.
control means no high steroid dose, opioids for anesthesia; paracetamol, NSAIDs and opioids as analgesia.
study protocol means methylprednisolone 125 mg and opioid free anesthesia followed by paracetamol, NSAIDs and if needed opioids as escape.
研究概览
详细说明
study group means for Anesthesia:
- High dose corticoids pre-operative: 125 mg Methylprednisolone. (Medrol) pre incision and 24h postoperative
- OFA using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg).
- Avoid opioids post-operative by using multimodal non-opioid analgesics after OFA. Avoid epidural to allow rapid mobilization.
all patients get Tranexamic acid 1 g (2 amp Exacyl 500mg) before and 1 g after surgery. It act as antifibrinolytic to reduce postoperative bleeding. (reversibly binding to lysine receptor sites on plasminogen) Try to give Continuous deep neuromuscular block (NMB) with a post titanic count (PTC) < 3 by continuous infusion and monitoring of NMB.
Intravenous Fluid restrictions to 1 ml/kg/h as long as pulse pressure (or plethysmograph) variation < 20% to reduce wound edema.
The pericapsular injections of local anesthetic, provided the patient had no contraindications such as poor renal function or allergies. 100 ml Ropivacaine 0,2% (max dose 3 mg/kg) + additives (Adrenaline 2,5 cc) (Ropivacaine: max 3 mg/kg)
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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Brugge、比利时、8000
- Azsintjan
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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:
- arthroplasty by anterior approach
Exclusion Criteria:
- allergy or impossible to use any of the drugs included
- revision procedure
- major cardiovascular, pulmonary or renal insufficiency requiring planned post operative intensive care admission
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：control group opioid anesthesia
standard anesthesia using opioids
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实验性的：study group opioid free anesthesia
opioid free anesthesia and high dose glucocorticoids
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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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QoR15
大体时间：measured at 24 hours after surgery.
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quality of recovery (QoR15) measured by 15 questions evaluating condition of recovery) scale 0 to 15 with 0 being very bad while 15 being maximum recovery possible or equal to pre operative state.
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measured at 24 hours after surgery.
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opioids postoperative
大体时间：measured at 24 hours after surgery.
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opioid use postoperative at 24 hours
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measured at 24 hours after surgery.
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CRP
大体时间：measured at 24 hours after surgery.
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Chronic reactive protein (CRP) change 24 h post-operative
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measured at 24 hours after surgery.
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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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surgical condition
大体时间：after surgery
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surgeon scores the surgical conditions on an adapted five-point Leyden scale
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after surgery
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muscle damage
大体时间：after surgery
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surgeon scores the muscle damage on an adapted five-point Leyden scale
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after surgery
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length of hospital stay
大体时间：until hospital discharge, maximum 7 days after surgery.
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number days patient stay in the hospital before discharge
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until hospital discharge, maximum 7 days after surgery.
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complications
大体时间：2 weeks postoperative
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complications up to two weeks postoperative
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2 weeks postoperative
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合作者和调查者
调查人员
- 研究主任：Marco Lanckneus, MD、AZSint Jan AV
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.
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