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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen NV, Denmark, 2400
    • Bispebjerg Hospital, Dept. of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Young (18-45 yrs), healthy males with no history of lung diseases.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Bilateral dual TAP-block
Placebo Bilateral dual TAP-block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Forced expiratory volume in 1 second (FEV1)	1 hour after application of the BD-TAP-block

Secondary Outcome Measures

Outcome Measure	Time Frame
Expiratory/Inspiratory pressure	1 hour after application of the BD-TAP-block

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Study Director: Christian P. Maschmann, MD, Bispebjerg Hospital; Principal Investigator: Maria Petersen, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): September 23, 2011
• Last Update Submitted That Met QC Criteria: September 22, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: pulmonary function; BD-TAP-block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: H-2-2010-080