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

Sponsor

Bispebjerg Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01254812

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Post Operative Pain

Study Design

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 :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Bilateral dual TAP-block
Placebo Bilateral dual TAP-block

Outcome Measures

Primary Outcome Measures

Forced expiratory volume in 1 second (FEV1) [1 hour after application of the BD-TAP-block]

Secondary Outcome Measures

Expiratory/Inspiratory pressure [1 hour after application of the BD-TAP-block]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christian Maschmann, MD, Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT01254812

Other Study ID Numbers:

H-2-2010-080

First Posted:

Dec 7, 2010

Last Update Posted:

Sep 23, 2011

Last Verified:

Sep 1, 2011

Keywords provided by Christian Maschmann, MD, Bispebjerg Hospital

pulmonary function

BD-TAP-block

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Sep 23, 2011