Post Operative PainNCT01254812
Does the Application of a Bilateral-dual Transverse Abdominal Plane (TAP)Block Have an Influence on Lung Function?
An observational study of Post Operative Pain, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Young (18-45 yrs), healthy males with no history of lung diseases.
Who may be able to join
- No history of asthma
- Young male
- Has to be able to conduct lung function examination and the application of abdominal nerve block
Who cannot join
- History of asthma
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Dept. of Anesthesiology
Copenhagen NV, 2400
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral dual TAP-block | Not described | |
| Placebo Bilateral dual TAP-block | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1)
Measured: 1 hour after application of the BD-TAP-block
Secondary outcomes (1)
Expiratory/Inspiratory pressure
Measured: 1 hour after application of the BD-TAP-block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Maschmann, Bispebjerg Hospital
- Investigators
- Christian P. Maschmann, MD, Study director, Bispebjerg HospitalMaria Petersen, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254812
- Sponsor's protocol ID
- H-2-2010-080
- Status last verified
- Sep 2011
- First submitted
- 3 Dec 2010
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes on Pulmonary Function After Application of a Bilateral-dual TAP-block
- ClinicalTrials.gov ID
- NCT01254812
- Acronym / sponsor ID
- H-2-2010-080
- Conditions
- Post Operative Pain
- Keywords
- pulmonary function, BD-TAP-block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral dual TAP-block | – | – |
| Placebo Bilateral dual TAP-block | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young (18-45 yrs), healthy males with no history of lung diseases.
Key inclusion criteria (3 listed)
- No history of asthma
- Young male
- Has to be able to conduct lung function examination and the application of abdominal nerve block
Key exclusion criteria (1 listed)
- History of asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forced expiratory volume in 1 second (FEV1)
Time frame: 1 hour after application of the BD-TAP-block
1 secondary outcome
Expiratory/Inspiratory pressure
Time frame: 1 hour after application of the BD-TAP-block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian P. Maschmann, MD study director
Bispebjerg Hospital
Maria Petersen, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in 1 second (FEV1) (time frame: 1 hour after application of the BD-TAP-block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2011.