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

February 6, 2024 updated by: Guillaume LONJON, Clinique Saint Jean, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34430
        • Recruiting
        • Clinique St Jean sud de france
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAP Block
Drug: Levobupivacaine
Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml
Placebo Comparator: saline solution
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption
Time Frame: 72hours
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
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
72hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Saint Jean, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00970-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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