Aortic Aneurysm, AbdominalPhase 4TAP-CACAONCT03657979
TAP-Block in Abdominal Aortic Surgery
A Phase 4 study testing Ropivacaine in people with Aortic Aneurysm, Abdominal, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2011to 29 Aug 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open abdominal aortic surgery (aneurysm or aortobifemoral bypass)
- Person who has given his written consent
Who cannot join
- Emergency surgery
- Patient with infection
- Use of opioids in the long term
- History of chronic pain
- Higher functions incompatible with the functioning of the PCA
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo
The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Ropivacaine, Placebo
- Keywords
- analgesia, TAP-block
- Medical subject headings
- Aortic Aneurysm, Abdominal, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
TAP-block Ropivacaine 0.2% during 48 hours
PlaceboDrug
TAP-block with placebo
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Conventional PCA morphine +TAP-block ropivacaine 0.2% Receives: Drug: Ropivacaine |
| TAP-block with placebo | Placebo comparator | Conventional PCA morphine treatment with TAP-block with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of morphine consumption at 24 postoperative hours
Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours
Measured: 24 hours
Secondary outcomes (1)
Evaluation of Visual Analogue Scale scores at 24 postoperative hours
Visual Analogue Scale scores statement during the first 24 postoperative hours (minimum pain 0 - maximum pain 10)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start5 Sep 2011
- Primary completion29 Aug 2012
- Study completion29 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric STEINMETZ, Centre Hospitalier Universitaire Dijon
- Investigators
- Claude GIRARD, Professor, Principal investigator, Anesthesia unitEric STEINMETZ, Professor, Principal investigator, Cardiovascular and thoracic surgery unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657979
- Sponsor's protocol ID
- 2011-002355-34
- Acronym
- TAP-CACAO
- Status last verified
- Sep 2018
- First submitted
- 29 Jun 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo
- ClinicalTrials.gov ID
- NCT03657979
- Acronym / sponsor ID
- TAP-CACAO / 2011-002355-34
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- analgesia, TAP-block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Sep 2011 (actual)
- Primary completion
- 29 Aug 2012 (actual)
- Study completion
- 29 Aug 2012 (actual)
- First posted
- 5 Sep 2018 (actual)
- 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.
The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: RopivacaineConventional PCA morphine +TAP-block ropivacaine 0.2% |
| TAP-block with placebo | Placebo comparator | Drug: PlaceboConventional PCA morphine treatment with TAP-block with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Open abdominal aortic surgery (aneurysm or aortobifemoral bypass)
- Person who has given his written consent
Key exclusion criteria (6 listed)
- Emergency surgery
- Patient with infection
- Use of opioids in the long term
- History of chronic pain
- Higher functions incompatible with the functioning of the PCA
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 |
|---|---|---|
| RopivacaineTAP-block Ropivacaine 0.2% during 48 hours | Drug | Ropivacaine |
| PlaceboTAP-block with placebo | Drug | TAP-block with placebo |
Primary outcome
Evaluation of morphine consumption at 24 postoperative hours
Time frame: 24 hours
Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours
1 secondary outcome
Evaluation of Visual Analogue Scale scores at 24 postoperative hours
Time frame: 24 hours
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 5 Sep 2018.
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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.
Claude GIRARD, Professor principal investigator
Anesthesia unit
Eric STEINMETZ, Professor principal investigator
Cardiovascular and thoracic surgery unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Aortic Aneurysm, Abdominal, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 2 inclusion and 6 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 5 Sep 2018. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of morphine consumption at 24 postoperative hours (time frame: 24 hours). 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 5 Sep 2018.