Kidney TransplantPhase 4NCT02080728
Transversus Abdominis Plane Block During Kidney Transplant Surgery
A Phase 4 study testing Ropivacaine 500mg/100ml Naropeine and 0.9% sodium chloride BAXTER in people with Kidney Transplant, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Ropivacaine 500mg/100ml Naropeine and 0.9% sodium chloride BAXTER
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2013to 9 Jul 2014
- 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
- Adult, Older adult
Who may be able to join
- Patient opéré for kidney transplant
- Patients who have provided written informed consent
- Patients with national health insurance cover
- Patients aged 18 years and above
Who cannot join
- Pregnant or breast-feeding women
- allergies/hypersensitivity to paracetamol (or propacetamol chlorhydrate (paracetamol pro-drug) or one of its excipients), to local anesthetics, morphines (or other constituents)
- patients under guardianship or ward of court
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane Block During Kidney Transplant Surgery: Prospective Controlled Randomized Double-blind Trial Comparing Ropivacaine 0.2% With Placebo.
The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo.
This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above.
This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.
- Conditions
- Kidney Transplant
- Being tested
- Ropivacaine 500mg/100ml Naropeine, 0.9% sodium chloride BAXTER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 500mg/100ml NaropeineDrug
0.9% sodium chloride BAXTERDrug
| Study group | Role | What they receive |
|---|---|---|
| TAP-Bloc | Experimental | Not described Receives: Drug: Ropivacaine 500mg/100ml Naropeine |
| Control | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride BAXTER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesurement of VAS (Visual analogue scale) scores for pain
Measured: During the first 24 hours post-op
Secondary outcomes (1)
Measurement of analgesic consomption
Measured: During the first 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study start23 Jul 2013
- Primary completion9 Jul 2014
- Study completion9 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080728
- Sponsor's protocol ID
- Jazayeri-Steinmetz AOI 2012
- Status last verified
- Dec 2018
- First submitted
- 5 Mar 2014
- Last updated
- 21 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block During Kidney Transplant Surgery: Prospective Controlled Randomized Double-blind Trial Comparing Ropivacaine 0.2% With Placebo.
- ClinicalTrials.gov ID
- NCT02080728
- Acronym / sponsor ID
- Jazayeri-Steinmetz AOI 2012
- Conditions
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- 9 Jul 2014 (actual)
- Study completion
- 9 Jul 2014 (actual)
- First posted
- 6 Mar 2014 (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.
The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo.
This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above.
This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP-Bloc | Experimental | Drug: Ropivacaine 500mg/100ml Naropeine |
| Control | Placebo comparator | Drug: 0.9% sodium chloride BAXTER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient opéré for kidney transplant
- Patients who have provided written informed consent
- Patients with national health insurance cover
- Patients aged 18 years and above
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding women
- allergies/hypersensitivity to paracetamol (or propacetamol chlorhydrate (paracetamol pro-drug) or one of its excipients), to local anesthetics, morphines (or other constituents)
- patients under guardianship or ward of court
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 500mg/100ml Naropeine | Drug | TAP-Bloc |
| 0.9% sodium chloride BAXTER | Drug | Control |
Primary outcome
Mesurement of VAS (Visual analogue scale) scores for pain
Time frame: During the first 24 hours post-op
1 secondary outcome
Measurement of analgesic consomption
Time frame: During the first 24 hours post-op
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 21 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 500mg/100ml Naropeine and 0.9% sodium chloride BAXTER in people with Kidney Transplant, 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 4 inclusion and 3 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 21 Dec 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?
Mesurement of VAS (Visual analogue scale) scores for pain (time frame: During the first 24 hours post-op). 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 21 Dec 2018.