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

NCT01254812 | Completed DMC

• 1 other identifier: H-2-2010-080
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

pulmonary function; BD-TAP-block

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in 1 second (FEV1)

  1 hour after application of the BD-TAP-block

Secondary Outcomes (1)

• Expiratory/Inspiratory pressure

  1 hour after application of the BD-TAP-block

Study Arms (2)

Bilateral dual TAP-block

Placebo Bilateral dual TAP-block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• No history of asthma
• Young male
• Has to be able to conduct lung function examination and the application of abdominal nerve block

You may not qualify if:

• History of asthma

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital, Dept. of Anesthesiology

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Christian P. Maschmann, MD

  Bispebjerg Hospital

  STUDY DIRECTOR

• Maria Petersen, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

DK (1)