Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
赞助:
New York University School of Medicine
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | November 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 |
amount (mg) of narcotics (oral morphine mg equivalents) used[ Time Frame: 6 Months ] Number of mgs taken of oral morphine duration of narcotic use[ Time Frame: 6 Months ] Number of days on morphine post surgery patient reported pain scores using VAS score[ Time Frame: 6 Months ] Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
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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 | Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery | ||
| 正式标题 ICMJE | Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery | ||
| 简要概况 | This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 4 | ||
| 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 |
400 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2020 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture Exclusion Criteria: - Pregnant women - Treatment with Arthroplasty - Patients who receive a peripheral nerve block - Patients who receive intra-op or post-op ketamine - Patients with concomitant TBI or MR - Polytrauma patients - Pathologic Fractures - Patients who live greater than 10 miles from NYU or who will not be followed by an NYU provider - Patients with a contraindication to any of the medications on the study list due to other medical problems such as renal or liver disease or due to allergy/intolerance - Patients with prior extremity weakness resulting from stroke or other neurological condition - Prior or current history of narcotic use - Patients with advanced dementia - NYUMC Students, Residents, Faculty | ||
| 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 | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 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 | New York University School of Medicine | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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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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