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临床试验/NCT03677778
NCT03677778已完成不适用

Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

Stanford University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年10月22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
43
试验地点
2
主要终点
Change in forced vital capacity (FVC)

研究概览

简要总结

One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.

The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.

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 (Participant, Investigator)

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in forced vital capacity (FVC)

时间窗: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)

Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.

Change in peak expiratory flow (PEF)

时间窗: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)

Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.

Change in forced expiratory volume in 1 second (FEV1)

时间窗: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)

Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.

次要结局

  • Pain scores(Pain scores will be assessed before nerve block is placed, within 1 hour after the surgery, while receiving either the placebo or treatment. (1 minute each for a total of 3 assessments))
  • Brachial plexus sensory and motor exam(Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (2 minutes each for a total of 3 assessments).)
  • Diaphragmatic excursion(Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (5 minutes each for a total of 3 assessments.))

研究者

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

Chi-Ho Ban Tsui

Professor

Stanford University

研究点 (2)

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