Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery
追踪信息 | |||
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首次提交日期 ICMJE | October 2, 2018 | ||
首次发布日期e ICMJE | October 5, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | November 1, 2018 | ||
预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Total morphine consumption (mg)[ Time Frame: 24 hours postoperatively ] |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery | ||
正式标题 ICMJE | Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia | ||
简要概况 | Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral nerve (femoral nerve block). Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with a femoral nerve block, without decreasing the functional parameters. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
60 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | November 1, 2021 | ||
预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Patient scheduled for a total knee arthroplasty under spinal block. - Patient with a weight above 40kg. Exclusion Criteria: - Patient with ASA IV status. - Contraindication to spinal block, femoral nerve block or tibial nerve block. - Neurological deficit of the lower limb. - Patient with renal dysfunction. - Patient with chronic pain, opioid consumption or alcohol consumption. - Pregnancy. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Eric Albrecht,Centre Hospitalier Universitaire Vaudois | ||
研究赞助商 ICMJE | Centre Hospitalier Universitaire Vaudois | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Centre Hospitalier Universitaire Vaudois | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |