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

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. Identifier: NCT01254812
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : September 23, 2011
Information provided by (Responsible Party):
Christian Maschmann, Bispebjerg Hospital

Brief Summary:

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.

Condition or disease
Post Operative Pain

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Changes on Pulmonary Function After Application of a Bilateral-dual TAP-block
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Bilateral dual TAP-block
Placebo Bilateral dual TAP-block

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 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

Responsible Party: Christian Maschmann, MD, Bispebjerg Hospital Identifier: NCT01254812     History of Changes
Other Study ID Numbers: H-2-2010-080
First Posted: December 7, 2010    Key Record Dates
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