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Completed

NCT Number: NCT06002217

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

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.

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Key information

Conditions

Fusion of Spine, Lumbar Region

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique St jean sud de france

Montpellier, 34430, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

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

Placebo Tap block

Other

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

Primary outcomes

  1. Analgesic consumption

    Time frame: 72hours

    The use of analgesics (oral or venous) during the during the 72 hours following surgery

Secondary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Official study title

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

Acronym: TAP ALIF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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