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临床试验/NCT03596190
NCT03596190已完成不适用

Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With the Double Injection Technique

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年8月21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
35
试验地点
2
主要终点
Frequency of hemi-diaphragmatic paresis

研究概览

简要总结

The investigators plan to determine the onset time and incidence of hemidiaphragmatic paresis (HDP) with a double injection supraclavicular nerve block in patients presenting for upper extremity surgery below the elbow.

The hypothesis is HDP following supraclavicular brachial plexus block occurs with-in 15 minutes of block performance and is not associated with subjective dyspnea.

详细描述

This study will be an observational trial to assess the onset time and incidence of hemidiaphragmatic paresis in patients who undergo the double injection ultrasound-guided supraclavicular block. Diaphragmatic dysfunction will be determined by intercostal diaphragm thickening measured using ultrasound. The available image will be saved.

Patients having below the elbow surgery will be be approached by someone from the research team for consent and possible inclusion in the study. This will be done in the anesthesia preoperative assessment clinic, or in the pre-op area on the day of surgery (if a patient was not seen in clinic).

A baseline ultrasonographic diaphragmatic assessment will be completed. Study participants will then receive supraclavicular brachial plexus block as per standard of care. Ultrasonographic diaphragmatic assessment and dyspnea score (using modified Borg dyspnea scale) will be performed every 5 minutes for 30 minutes, or until the patient is transferred to the operating room, whatever comes first. Patients will also undergo an ultrasonographic diaphragmatic assessment and dyspnea score in the recovery room after their surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Patients presenting for unilateral upper extremity surgery below the level of the elbow (the forearm or hand) who are having a double injection regional block for anesthesia
  • 18 years old and over
  • Weight 50kg or greater
  • English speaking
  • American Society of Anesthesiologists physical status 1-3

排除标准

  • Known Chronic Obstructive Pulmonary Disease
  • Pregnancy
  • Any significant neurologic dysfunction, or inability to visualize the diaphragm during baseline sonographic assessment

结局指标

主要结局

Frequency of hemi-diaphragmatic paresis

时间窗: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)

Number of participants in which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening

Onset time of hemi-diaphragmatic paresis

时间窗: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block

The average time at which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening

次要结局

  • The correlation of subjective dyspnea(Baseline, 5, 10, 15, 20, 25, and 30 minutes after block)
  • Incidence of HDP after surgical procedure under supraclavicular brachial plexus block (in post recovery unit).(Post-operatively up to 24 hours)

研究者

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

Vishal Uppal

Principal Investigator

Nova Scotia Health Authority

研究点 (2)

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