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临床试验/NCT01263249
NCT01263249已完成4 期

Continuous Femoral Nerve Blocks: Effects of Catheter Tip Location Relative to the Femoral Nerve on Sensory and Motor Function

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
19
试验地点
1
主要终点
Quadriceps femoris muscle strength

研究概览

简要总结

To determine if the way local anesthetic, or numbing medication, is delivered through a tiny tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.

详细描述

Specific Aim: Research study to test the hypothesis that differing the location of the perineural catheter tip during a continuous femoral nerve block (anterior vs. posterior) impacts quadriceps muscle strength. These results will help define the optimal perineural catheter tip location relative to the femoral nerve used for continuous peripheral nerve blocks and help guide both clinical care and future research in this clinically-relevant area.

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
Triple (Participant, Care Provider, 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
是

入选标准

  • •18 years of age or over
  • •Willing to have bilateral femoral perineural catheters placed with a subsequent ropivacaine infusion and motor/sensory testing for 6 hours, requiring an overnight stay in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning

排除标准

  • •current daily analgesic use
  • •opioid use within the previous 4 weeks
  • •any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
  • •body mass index > 30 kg/m2
  • •pregnancy
  • •incarceration

研究组 & 干预措施

Catheter Anterior to Femoral Nerve

Active Comparator

Each subject will have one lower extremity (Right or Left) randomized to receive a perinural catheter, placed anterior to the femoral nerve, with a continuous infusion of local anesthetic and then the outcomes will be measured.

干预措施: Catheter Anterior to the Femoral Nerve (Procedure)

Catheter Posterior to Femoral Nerve

Active Comparator

Each subject will have the opposite lower extremity (Right or Left) randomized to receive a perinural catheter, placed posterior to the femoral nerve, with a continuous infusion of local anesthetic and then the outcomes will be measured.

干预措施: Catheter Posterior to the Femoral Nerve (Procedure)

结局指标

主要结局

Quadriceps femoris muscle strength

时间窗: percentage of baseline muscle strength six hours after infusion initiation

The primary end point will be the quadriceps femoris maximum voluntary isometric contraction (MVIC) expressed as a percentage of the pre-ropivacaine MVIC: post / pre x 100; with the two sides of each subject compared with each other

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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