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Completed

NCT Number: NCT01254812

Does the Application of a Bilateral-dual Transverse Abdominal Plane (TAP)Block Have an Influence on Lung Function?

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Bispebjerg Hospital, Dept. of Anesthesiology

Copenhagen NV, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of asthma

Treatment and study plan

Primary outcomes

  1. Forced expiratory volume in 1 second (FEV1)

    Time frame: 1 hour after application of the BD-TAP-block

Secondary outcomes

  1. Expiratory/Inspiratory pressure

    Time frame: 1 hour after application of the BD-TAP-block

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 7, 2010
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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