ACB v FNB for Revision TKA
赞助:
University of Pennsylvania
合作者:
信息的提供 (责任方):
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追踪信息 | |||
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首次提交日期 ICMJE | October 3, 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 | October 2018 | ||
预计主要完成日期 | December 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 |
Quality of recovery-15 item questionnaire (QoR): QoR-15[ Time Frame: 48 hours after surgery ] Our primary objective will be to determine if FNBs will result in improved quality of recovery (QoR-15) compared with ACBs (at 48 hours). The questionnaire is 15 questions with a scale from 0-10 on each and composed of two parts; part A and Part B scoring for questions in part A ( questions from 1-10) are scored from 0-10 where 0=none of the time( poor), and 10= all of the time (excellent). Part Bare questions from 11-15 where they are scored from (10-0) where 10=none of the time ( excellent) and 0=all of the time ( poor). The sum of all answers are added together |
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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 | ACB v FNB for Revision TKA | ||
正式标题 ICMJE | The Effect of Femoral Nerve Block Versus Adductor Canal Block on the Quality of Recovery for Revision Total Knee Arthroplasty, a Prospective Randomized Blinded Study | ||
简要概况 | This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. The investigators seek to determine if femoral nerve block (FNB) improves the quality of recovery and improve postoperative analgesia compared with adductor canal block (ACBs) for patients undergoing revision total knee arthroplasty. |
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详细说明 | This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. A prospective study design will allow both FNBs and ACBs to be accurately assessed in an effective manner without introducing unnecessary confounding factors. Furthermore, randomization and a parallel design with equal allocation ratio will ensure timely enrollment of patients while also minimizing temporal confounders that may occur with institutional changes to clinical care protocols. Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment (FNB or ACB) | ||
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:Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment 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 |
150 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | July 2020 | ||
预计主要完成日期 | December 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Adult male or female patients ages 18-80 scheduled for elective revision TKA. - American Society of Anesthesiologists (ASA) physical status I -III - Mentally competent and able to give consent for enrollment in the study. Exclusion Criteria: - Patients with any contraindications to regional anesthesia such as infection, nerve injury, anticoagulation. - Patient refusal. - Patients with an allergy to local anesthetics or systemic opioids. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:80 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
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 | , | ||
研究赞助商 ICMJE | University of Pennsylvania | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
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 |
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