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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 7, 2010
Last Update Posted: September 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christian Maschmann, Bispebjerg Hospital

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.

Post Operative Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Changes on Pulmonary Function After Application of a Bilateral-dual TAP-block

Further study details as provided by Christian Maschmann, Bispebjerg Hospital:

Primary Outcome Measures:
  • Forced expiratory volume in 1 second (FEV1) [ Time Frame: 1 hour after application of the BD-TAP-block ]

Secondary Outcome Measures:
  • Expiratory/Inspiratory pressure [ Time Frame: 1 hour after application of the BD-TAP-block ]

Enrollment: 12
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Bilateral dual TAP-block
Placebo Bilateral dual TAP-block


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Young (18-45 yrs), healthy males with no history of lung diseases.

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254812

Bispebjerg Hospital, Dept. of Anesthesiology
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Study Director: Christian P. Maschmann, MD Bispebjerg Hospital
Principal Investigator: Maria Petersen, MD Bispebjerg Hospital
  More Information

Responsible Party: Christian Maschmann, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01254812     History of Changes
Other Study ID Numbers: H-2-2010-080
First Submitted: December 3, 2010
First Posted: December 7, 2010
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by Christian Maschmann, Bispebjerg Hospital:
pulmonary function

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms