Transversus Abdominis Plane BlockNCT01024868
Assessment of Spread of Transversus Abdominis Plane Block
An observational study of Transversus Abdominis Plane Block, run by Herlev Hospital at 1 site in Denmark.
Trial summary
For the purpose of assessing the spread of the local anaesthetic after injecting it between abdominal muscles on both sides, the investigators will test if the patient can feel a change in the perception of cold and warm, as well as being pricked with a blunt needle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transversus Abdominis Plane Block
- What is being tested?
- Ropivacaine 0,5%
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing abdominal surgery
Who may be able to join
- undergo abdominal surgery, eligible for TAP block, over 18, BMI 20-40
Who cannot join
- does not speak danish, does not consent, does not fulfill inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Spread of Transversus Abdominis Plane Block After Administration of 20 ml Ropivacaine 0,5% Bilaterally
For the purpose of assessing the spread of the local anaesthetic after injecting it between abdominal muscles on both sides, the investigators will test if the patient can feel a change in the perception of cold and warm, as well as being pricked with a blunt needle. The investigators will also take several blood samples, together with routine samples, to measure the concentration of the local anesthetic in the blood.
- Conditions
- Transversus Abdominis Plane Block
- Being tested
- Ropivacaine 0,5%
- Keywords
- Transversus Abdominis Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0,5%Drug
Injection of ropivacaine 0,5% 20 ml bilaterally before surgery
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Patients before undergoing laparoscopic or other abdominal surgery Receives: Drug: Ropivacaine 0,5% |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transversus Abdominis Plane BlockStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Investigators
- Ann M Møller, dr. med., Study director, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024868
- Sponsor's protocol ID
- TDTSG-1
- Status last verified
- Dec 2009
- First submitted
- 2 Dec 2009
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.
PubMed 22450529Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.
PubMed 22381092
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Spread of Transversus Abdominis Plane Block After Administration of 20 ml Ropivacaine 0,5% Bilaterally
- ClinicalTrials.gov ID
- NCT01024868
- Acronym / sponsor ID
- TDTSG-1
- Conditions
- Transversus Abdominis Plane Block
- Keywords
- Transversus Abdominis Plane Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (actual)
- First posted
- 3 Dec 2009 (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.
For the purpose of assessing the spread of the local anaesthetic after injecting it between abdominal muscles on both sides, the investigators will test if the patient can feel a change in the perception of cold and warm, as well as being pricked with a blunt needle. The investigators will also take several blood samples, together with routine samples, to measure the concentration of the local anesthetic in the blood.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAP block | – | Drug: Ropivacaine 0,5%Patients before undergoing laparoscopic or other abdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing abdominal surgery
Key inclusion criteria (1 listed)
- undergo abdominal surgery, eligible for TAP block, over 18, BMI 20-40
Key exclusion criteria (1 listed)
- does not speak danish, does not consent, does not fulfill inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0,5%Injection of ropivacaine 0,5% 20 ml bilaterally before surgery | Drug | TAP block |
Primary outcome
Not reported in the source record.
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 4 May 2010.
- Derived from this study: PubMed 22450529Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.
- Derived from this study: PubMed 22381092Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.
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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.
Ann M Møller, dr. med. study director
Herlev 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 Transversus Abdominis Plane Block, run by Herlev 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 1 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 4 May 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024868, which also lists 2 linked publications.
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 4 May 2010.