Fusion of Spine, Lumbar RegionTAP ALIFNCT06002217
Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF)
A study testing Levobupivacaine in people with Fusion of Spine, Lumbar Region, run by Clinique Saint Jean, France at 1 site in France.
Trial summary
The goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery. The main question it aims to answer : whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fusion of Spine, Lumbar Region
- What is being tested?
- Levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 9 Jul 2026
- Phase
- Interventional
- 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
- Patient affiliated or entitled to a social security plan.
- Patient who has been informed about the study and has co-signed a consent form with the investigator. consent to participate in the study.
- Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels.
- Patient with ASA criteria 1, 2 and 3.
Who cannot join
- Patients with intolerance or contraindication to paracetamol, anti-inflammatory or morphine.
- Patients allergic to local anesthetics.
- Pregnant or breast-feeding patient.
- patient undergoing cancer or trauma surgery trauma.
- Patient participating in another interventional study.
- Patient with a history of lumbar arthrodesis.
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- Patient refusing to sign consent form.
- Patient unable to give informed consent.
- Patient under court protection, guardianship or trusteeship.
- Patient not available for study follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF): Randomized, Double-blind, Controlled Trial.
The goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery.
The main question it aims to answer :
- whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and all postoperative pain medication will be recorded over 3 days.
Researchers will compare tap block vs placebo to see if it reduces postoperative pain.
- Conditions
- Fusion of Spine, Lumbar Region
- Being tested
- Levobupivacaine, Placebo Tap block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml
Placebo Tap blockOther
Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block
| Study group | Role | What they receive |
|---|---|---|
| TAP Block | Active comparator | Not described Receives: Drug: Levobupivacaine |
| saline solution | Placebo comparator | Not described Receives: Other: Placebo Tap block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
The use of analgesics (oral or venous) during the during the 72 hours following surgery
Measured: 72hours
Secondary outcomes (1)
Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10
Pain assessment for 72 hours after surgery, measured on a scale between 0 and 10 (VAS scale ), where 0 is no pain and 10 is maximum pain
Measured: 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Feb 2024
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusion of Spine, Lumbar RegionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume LONJON, Clinique Saint Jean, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002217
- Sponsor's protocol ID
- 2022-A00970-43
- Acronym
- TAP ALIF
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF): Randomized, Double-blind, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06002217
- Acronym / sponsor ID
- TAP ALIF / 2022-A00970-43
- Conditions
- Fusion of Spine, Lumbar Region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 21 Aug 2023 (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 goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery.
The main question it aims to answer :
- whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and all postoperative pain medication will be recorded over 3 days.
Researchers will compare tap block vs placebo to see if it reduces postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block | Active comparator | Drug: Levobupivacaine |
| saline solution | Placebo comparator | Other: Placebo Tap block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient affiliated or entitled to a social security plan.
- Patient who has been informed about the study and has co-signed a consent form with the investigator. consent to participate in the study.
- Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels.
- Patient with ASA criteria 1, 2 and 3.
Key exclusion criteria (10 listed)
- Patients with intolerance or contraindication to paracetamol, anti-inflammatory or morphine.
- Patients allergic to local anesthetics.
- Pregnant or breast-feeding patient.
- patient undergoing cancer or trauma surgery trauma.
- Patient participating in another interventional study.
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 |
|---|---|---|
| LevobupivacainePatients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml | Drug | TAP Block |
| Placebo Tap blockPatients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block | Other | saline solution |
Primary outcome
Analgesic consumption
Time frame: 72hours
The use of analgesics (oral or venous) during the during the 72 hours following surgery
1 secondary outcome
Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10
Time frame: 72hours
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 10 Jul 2026.
- Individual participant dataSharing planned: No
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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 study testing Levobupivacaine in people with Fusion of Spine, Lumbar Region, run by Clinique Saint Jean, France 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 10 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 10 Jul 2026. 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.
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?
Analgesic consumption (time frame: 72hours). 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 10 Jul 2026.