Does the Application of a Bilateral-dual Transverse Abdominal Plane (TAP)Block Have an Influence on Lung Function?
|ClinicalTrials.gov Identifier: NCT01254812|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : September 23, 2011
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|
|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|
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: 1 hour after application of the BD-TAP-block ]
- Expiratory/Inspiratory pressure [ Time Frame: 1 hour after application of the BD-TAP-block ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254812
|Bispebjerg Hospital, Dept. of Anesthesiology|
|Copenhagen NV, Denmark, 2400|
|Study Director:||Christian P. Maschmann, MD||Bispebjerg Hospital|
|Principal Investigator:||Maria Petersen, MD||Bispebjerg Hospital|