跳至主要内容
临床试验/NCT01226927
NCT01226927已完成不适用

The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Intravenous patient-controlled analgesia opioid consumption

研究概览

简要总结

The optimal infusion technique (continuous rate vs. intermittent bolus) for peripheral nerve blocks has not been established. To our knowledge, this is the first study to compare the efficacy of an automated intermittent bolus technique to a continuous rate of infusion of local anesthetic in femoral nerve catheters. We hypothesized that the intermittent bolus technique would provide enhanced analgesia compared to a continuous infusion rate as assessed by intravenous patient-controlled analgesia (IV-PCA) hydromorphone consumption and visual analog scale (VAS) pain scores.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status 1 through 3
  • elective, primary, unilateral TKA

排除标准

  • patient refusal
  • pregnancy
  • diabetic neuropathy or any other neurologic or neuromuscular disease
  • rheumatoid arthritis
  • current coagulopathy
  • skin infection at needle insertion site for the femoral or sciatic blocks
  • significant renal or hepatic impairment
  • unsuccessful femoral or sciatic block or femoral catheter placement
  • femoral catheter dislodgement after placement
  • inability to understand VAS pain scales
  • inability to use an IV-PCA pump

结局指标

主要结局

Intravenous patient-controlled analgesia opioid consumption

时间窗: Cumulative IV-PCA use was recorded until femoral nerve catheter removed on postoperative day 2.

Visual analog pain scale score

时间窗: Preop; Immediately postoperatively in PACU; Postoperative day (POD) 0 at 8pm; POD 1 at 8am, 2pm & 8pm; POD 2 at 8am

次要结局

  • Visual analog scale patient satisfaction scores(POD 1 at 8am; POD 2 at 8am)
  • Incidence of physician administered "rescue" boluses of the femoral nerve catheter
  • Hospital length of stay

研究者

申办方类型
Other

研究点 (2)

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