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

Not Applicable

Recruiting

• Conditions: Fusion of Spine, Lumbar Region
• Interventions: Other: Placebo Tap block; Drug: Levobupivacaine

• Registration Number: NCT06002217
• Lead Sponsor: Clinique Saint Jean, France

Brief 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 all postoperative pain medication will be recorded over 3 days.

Researchers will compare tap block vs placebo to see if it reduces postoperative pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Study Start: 2024-02-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline solution	Placebo Tap block	-
TAP Block	Levobupivacaine	-

Primary Outcome Measures

Name	Time	Method
Analgesic consumption	72hours	The use of analgesics (oral or venous) during the during the 72 hours following surgery

Secondary Outcome Measures

Name	Time	Method
Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10	72hours	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

Trial Locations

Locations (1)

Clinique St jean sud de france; 🇫🇷 Montpellier, France