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

NCT ID: NCT06002217

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2026-10-31

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.

Detailed Description

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Conditions

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Fusion of Spine, Lumbar Region

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TAP Block

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml

saline solution

Group Type PLACEBO_COMPARATOR

Placebo Tap block

Intervention Type OTHER

Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block

Interventions

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Levobupivacaine

Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml

Intervention Type DRUG

Placebo Tap block

Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint Jean, France

OTHER

Sponsor Role lead

Responsible Party

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Guillaume LONJON

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinique St jean sud de france

Montpellier, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Cecile Spirito

Role: primary

00304 67 41 34 53

Other Identifiers

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2022-A00970-43

Identifier Type: -

Identifier Source: org_study_id

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