Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF)

Study Overview
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Brief Summary
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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.

Official Title
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Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF): Randomized, Double-blind, Controlled Trial.

Conditions
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Fusion of Spine, Lumbar Region

Intervention / Treatment
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* Drug: Levobupivacaine
* Other: Placebo Tap block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP Block<br> | Drug: Levobupivacaine<br>* Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml<br>|
| Placebo Comparator: saline solution<br> | Other: Placebo Tap block<br>* Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | The use of analgesics (oral or venous) during the during the 72 hours following surgery | 72hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 72hours |