IPACK Block in Total Knee Arthroplasty
追踪信息 | |||
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首次提交日期 ICMJE | September 30, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | October 2018 | ||
预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
NRS scores[ Time Frame: 48 hours ] Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever) Morphine consumption[ Time Frame: 24 hours ] Morphine consumption in mg Chronic pain[ Time Frame: 6 months ] Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting |
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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 | IPACK Block in Total Knee Arthroplasty | ||
正式标题 ICMJE | IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study | ||
简要概况 | 100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | Phase 2 | ||
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 |
100 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | July 2019 | ||
预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Physical status according to American Society of Anesthesiologists (ASA) I-III - Patients scheduled for total knee arthroplasty Exclusion Criteria: - Previous operation on same knee - Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol - BMI above 32 - Serious psychiatric, mental and cognitive disorders - Language barrier - Block failure - Chronic opioid, gabapentinoid use - Severe kidney disfunction | ||
性别 |
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年龄 | 最小年龄:14 Years ,最大年龄:80 Years | ||
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 | Alexandros Makris,Asklepieion Voulas General Hospital | ||
研究赞助商 ICMJE | Asklepieion Voulas General Hospital | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Asklepieion Voulas General Hospital | ||
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 |