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

Post Operative Pain Clinical Trial

Official title:

Changes on Pulmonary Function After Application of a Bilateral-dual TAP-block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254812
• Other study ID #: H-2-2010-080
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: September 22, 2011
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Dept. of Anesthesiology	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in 1 second (FEV1)		1 hour after application of the BD-TAP-block	No
Secondary	Expiratory/Inspiratory pressure		1 hour after application of the BD-TAP-block	No