Fascia Iliaca Blocks for Total Hip Arthroplasty
赞助:
New York School of Regional Anesthesia
合作者:
信息的提供 (责任方):
Catherine Vandepitte, M.D.，New York School of Regional Anesthesia
| 追踪信息 | |||
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| 首次提交日期 ICMJE | August 1, 2018 | ||
| 首次发布日期e ICMJE | October 1, 2018 | ||
| 最后更新发布日期 | October 1, 2018 | ||
| 预计研究开始日期 ICMJE | May 15, 2018 | ||
| 预计主要完成日期 | December 31, 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 0 ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with movement Current pain assessed by numeric rating scale (NRS)[ Time Frame: PACU arrival ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: PACU discharge ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: 6 hours ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: 12 hours ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: 24 hours ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: 36 hours ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: 48 hours ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 2 evening ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 3 morning ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 3 evening ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 4 ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 5 ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 6 ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with Current pain assessed by numeric rating scale (NRS)[ Time Frame: Day 7 ] Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with |
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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 | Fascia Iliaca Blocks for Total Hip Arthroplasty | ||
| 正式标题 ICMJE | Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty | ||
| 简要概况 | The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated. |
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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 | Recruiting | ||
| 预计入组 ICMJE |
75 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 31, 2019 | ||
| 预计主要完成日期 | December 31, 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Male or female, at least 18 years of age at screening - Scheduled for unilateral DAA THA - American Society of Anesthesiologists (ASA) physical status 1, 2 or 3 - Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold - Able to ambulate - Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Exclusion Criteria: - Previous open hip surgery - History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics - Contraindication to bupivacaine or morphine - Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments - Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®) - Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2 - Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments | ||
| 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 | Belgium | ||
| 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: 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 | Catherine Vandepitte, M.D.，New York School of Regional Anesthesia | ||
| 研究赞助商 ICMJE | New York School of Regional Anesthesia | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | New York School of Regional Anesthesia | ||
| 验证日期 | September 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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