Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06002217

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

Led by Clinique Saint Jean, France · Updated on 2026-01-06

80

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of a transverse abdominal plane (TAP) block compared to a placebo in adults undergoing anterior lumbar spine surgery. The main goal is to determine whether the TAP block can reduce the need for pain medication after surgery. This randomized, double-blind, controlled trial is sponsored by Clinique Saint Jean, France, and focuses on patients having abdominal disc surgery at one or two levels. Participants will be randomly assigned to receive either an injection of levobupivacaine 2.5mg/ml as the TAP block or an injection of saline solution 2.5mg/ml as the placebo. Both injections are administered in the same way. The study will monitor pain medication use and pain levels for 72 hours after surgery. During the study, participants' consumption of pain medication will be closely recorded for three days after surgery. Pain will also be assessed using a visual analogue scale from 0 to 10 over the same period. Researchers will observe the effects of the TAP block on postoperative pain and analgesic use. The study will continue until October 2026, with safety and follow-up assessments included.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient affiliated or entitled to a social security plan
  • Patient who has been informed about the study and has co-signed a consent form
  • Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels
  • Patient with ASA criteria 1, 2 and 3
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants receive either an injection of levobupivacaine or a placebo tap block during their abdominal disc surgery.

1 visit (in-person)

Post-operative Follow-up

Duration - 72 hours

Participants are monitored for pain and analgesic consumption for 72 hours after surgery.

Multiple assessments during 72 hours post-surgery

Trial Site Locations

Total: 1 location

1

Clinique St jean sud de france

Montpellier, France, 34430

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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