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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Maschmann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01254812
First received: December 3, 2010
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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
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 Bispebjerg Hospital:

Primary Outcome Measures:
  • Forced expiratory volume in 1 second (FEV1) [ Time Frame: 1 hour after application of the BD-TAP-block ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expiratory/Inspiratory pressure [ Time Frame: 1 hour after application of the BD-TAP-block ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
Bilateral dual TAP-block
Placebo Bilateral dual TAP-block

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01254812

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

No publications provided

Responsible Party: Christian Maschmann, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01254812     History of Changes
Other Study ID Numbers: H-2-2010-080
Study First Received: December 3, 2010
Last Updated: September 22, 2011
Health Authority: Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:
pulmonary function
BD-TAP-block

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014