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临床试验/NCT01254812
NCT01254812已完成不适用

Changes on Pulmonary Function After Application of a Bilateral-dual TAP-block

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年10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
12
试验地点
1
主要终点
Forced expiratory volume in 1 second (FEV1)

研究概览

简要总结

TAP-block (Transverse Abdominal Plane) block is a method of regional anesthesia used after abdominal surgery. The method is often applied ultra-sound guided.

In our department, the so-called bilateral dual TAP-block (BD-TAP-block) has been developed. This includes injection of local anesthetics at four sites on the abdominal wall, aiming at the best possible spread of the nerve block.

Clinical experience shows satisfying results on pain relieve using the nerve block, i.e the sensory nerves of the abdominal wall are successfully blocked. However, to our knowledge, clinical investigations regarding the effect on the muscles of the abdominal wall has never been executed.

Patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. Therefore it would be inappropriate if the motor nerves supplying these muscles were too, affected by the nerve block.

Our clinical experience has so far not given us suspicion or indication that the motor nerves become blocked, although these nerves are situated in the same muscle layer as the sensory branches.

Hence the investigators would like to examine on healthy, male subjects, whether application of a bilateral-dual TAP-block effects their ability to perform peak-flow and inspiratory and expiratory pressure. Our study hypothesis is:

There is no clinically relevant difference in the spread of results of pulmonary tests (peak flow et.c.) before and after application of bilateral dual TAP-block.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • No history of asthma
  • Young male
  • Has to be able to conduct lung function examination and the application of abdominal nerve block

排除标准

  • History of asthma

结局指标

主要结局

Forced expiratory volume in 1 second (FEV1)

时间窗: 1 hour after application of the BD-TAP-block

次要结局

  • Expiratory/Inspiratory pressure(1 hour after application of the BD-TAP-block)

研究者

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

Christian Maschmann

MD

Bispebjerg Hospital

研究点 (1)

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