Elective Surgery of the Spine by LaparotomyPhase 4TAPBloc RachisNCT02055664
The Tap Block Technique Via the Anterior Approach in Elective Surgery of the Spine
A Phase 4 study testing Ropivacaine 0.2% and Chlorure de sodium 0.9% in people with Elective Surgery of the Spine by Laparotomy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo. Procedure: Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery of the Spine by Laparotomy
- What is being tested?
- Ropivacaine 0.2% and Chlorure de sodium 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2014to 12 Aug 2015
- 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
- Patients over 18 yo who have provided written informed consent
- Patients with an indication for elective spinal surgery using laparotomy
- Patients with national health insurance cover
Who cannot join
- Adults under guardianship
- Pregnant or breast-feeding women
- allergies or contra-indication for paracetamol, morphine-based drugs
- Contra-indication for ropivacaine
- Contra-indication for sodium chloride
- inability to understand PCA (patient-controlled anaesthesia)
- Hypersensitivity to ropivacaine or to other aminoamide local anaesthetics
- Hypovolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE TAP BLOCK TECHNIQUE VIA THE ANTERIOR APPROACH IN ELECTIVE SURGERY OF THE SPINE: Prospective, Randomised, Double Blind Trial, Comparing TAP BLOCK With Continuous Infiltration of Ropivacaine Versus Placebo
This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.
Procedure:
Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.
- Being tested
- Ropivacaine 0.2%, Chlorure de sodium 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2%Drug
Chlorure de sodium 0.9%Drug
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: Chlorure de sodium 0.9% |
| control | Placebo comparator | Not described Receives: Drug: Ropivacaine 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of morphine in mg
Measured: First 48 hours following the surgery
Secondary outcomes (1)
Intensity of pain
Measured: First 48 hours following the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start23 Jan 2014
- Primary completion12 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgery of the Spine by LaparotomyStudies 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
- 80 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
- NCT02055664
- Sponsor's protocol ID
- MIREK 2013
- Acronym
- TAPBloc Rachis
- Status last verified
- May 2019
- First submitted
- 4 Feb 2014
- Last updated
- 6 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE TAP BLOCK TECHNIQUE VIA THE ANTERIOR APPROACH IN ELECTIVE SURGERY OF THE SPINE: Prospective, Randomised, Double Blind Trial, Comparing TAP BLOCK With Continuous Infiltration of Ropivacaine Versus Placebo
- ClinicalTrials.gov ID
- NCT02055664
- Acronym / sponsor ID
- TAPBloc Rachis / MIREK 2013
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 23 Jan 2014 (actual)
- Primary completion
- 12 Aug 2015 (actual)
- First posted
- 5 Feb 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.
This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.
Procedure:
Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Chlorure de sodium 0.9% |
| control | Placebo comparator | Drug: Ropivacaine 0.2% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 yo who have provided written informed consent
- Patients with an indication for elective spinal surgery using laparotomy
- Patients with national health insurance cover
Key exclusion criteria (8 listed)
- Adults under guardianship
- Pregnant or breast-feeding women
- allergies or contra-indication for paracetamol, morphine-based drugs
- Contra-indication for ropivacaine
- Contra-indication for sodium chloride
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 0.2% | Drug | control |
| Chlorure de sodium 0.9% | Drug | treatment |
Primary outcome
Consumption of morphine in mg
Time frame: First 48 hours following the surgery
1 secondary outcome
Intensity of pain
Time frame: First 48 hours following the surgery
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 6 May 2019.
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 0.2% and Chlorure de sodium 0.9% in people with Elective Surgery of the Spine by Laparotomy, 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 3 inclusion and 8 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 6 May 2019. 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?
Consumption of morphine in mg (time frame: First 48 hours following the surgery). 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 6 May 2019.