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临床试验/NCT03208478
NCT03208478已完成不适用

A Prospective Comparison of Pain and Quality of Recovery in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Adductor Canal or Femoral Perineural Infusions

Stanford University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain Score

研究概览

简要总结

Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries. Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful orthopedic procedure performed after traumatic injury to the knee. Many patients undergoing ACL reconstruction receive a nerve block as part of their anesthetic care. These blocks can be performed in different locations along the femoral nerve, with advantages and disadvantages to each location. Recently published evidence indicates that there is no short-term difference in pain control between the two commonly-targeted locations ("Adductor Canal" and "Femoral"). However, studies involving patients undergoing total knee arthroplasty indicate that femoral blocks provide better pain control with movement than adductor canal blocks. As many patients undergoing ACL reconstruction use continuous passive motion (CPM) machines as part of rehabilitation starting on post-operative day one, the investigators hypothesize that pain control and quality of recovery in the first 48 hours after surgery will be superior with a continuous femoral block than with a continuous adductor canal block. The investigators plan to study this by randomizing patients presenting for ACL reconstruction to receive either a continuous femoral or continuous adductor canal block (both considered adequate means of pain control), and following them to 48 hours to determine the level of pain, quality of recovery score, opioid use, and CPM compliance.

详细描述

covery score, opioid use, and CPM compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients >18 years
  • ASA physical status I, II, or III
  • Scheduled for ACL reconstruction surgery with patellar autograft

排除标准

  • Pregnancy
  • Incarceration
  • Pre-operative opioid use >15 mg morphine equivalents per day
  • Inability to communicate with investigators by telephone
  • Pre-existing neuropathy of the operative extremity

结局指标

主要结局

Pain Score

时间窗: Post-operative day 2

Participants will report pain on a numeric rating scale

次要结局

  • CPM compliance(POD 2)
  • Quality of Recovery(POD 2)
  • Opioid Use(POD 2)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Louis Horn

Professor-Med Ctr Line

Stanford University

研究点 (2)

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