LaparotomyPhase 2KTAPNCT01719796
Effect of TAP Block on Ventilatory Function Following Abdominal Surgery
A Phase 2 study testing Regional analgesia infusion in people with Laparotomy, run by Pierre and Marie Curie University at 2 sites in France.
Trial summary
Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy
- What is being tested?
- Regional analgesia infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2012to Dec 2014
- Phase
- Phase 2
- 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
- laparotomy
Who cannot join
- below 18, pregnancy, prisoners
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire de Nîmes
Nîmes
Philippe CUVILLON, MD, PhD, +33675303395, philippe.cuvillon@chu-nimes.fr
Philippe CUVILLON, MD, PhD
- Recruiting
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne
Serge MOLLIEX, MD, PhD, +33477120922, serge.molliex@chu-st-etienne.fr
Serge MOLLIEX, MD, PhD
About this study
Official title: Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.
Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.
- Conditions
- Laparotomy
- Being tested
- Regional analgesia infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional analgesia infusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bilateral TAP catheter | Experimental | Ultrasonography guided bilateral TAP catheter insertion. Receives: Procedure: Regional analgesia infusion |
| No TAP catheter | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital capacity
Measured: 72h
Secondary outcomes (4)
maximum forced expiratory flow
Measured: 72h
analgesic consumption
Measured: 72h
pain
resting pain, assessed using VAS
Measured: 72h
diaphragmatic course
using ultrasonography
Measured: 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu RAUX, Pierre and Marie Curie University
- Investigators
- Mathieu RAUX, MD, PhD, Study director, Pierre et Marie Curie University, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719796
- Sponsor's protocol ID
- KTAP
- Acronym
- KTAP
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT01719796
- Acronym / sponsor ID
- KTAP / KTAP
- Conditions
- Laparotomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Nov 2012 (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.
Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral TAP catheter | Experimental | Procedure: Regional analgesia infusionUltrasonography guided bilateral TAP catheter insertion. |
| No TAP catheter | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- laparotomy
Key exclusion criteria (1 listed)
- below 18, pregnancy, prisoners
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 |
|---|---|---|
| Regional analgesia infusion | Procedure or surgery | Bilateral TAP catheter |
Primary outcome
vital capacity
Time frame: 72h
4 secondary outcomes
maximum forced expiratory flow
Time frame: 72h
analgesic consumption
Time frame: 72h
pain
Time frame: 72h
diaphragmatic course
Time frame: 72h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
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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.
Mathieu RAUX, MD, PhD study director
Pierre et Marie Curie University, Paris, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regional analgesia infusion in people with Laparotomy, run by Pierre and Marie Curie University at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu RAUX, MD, PhD (+33142177379, mathieu.raux@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital capacity (time frame: 72h). 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 1 Nov 2012.