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

Fusion of Spine, Lumbar Region Clinical Trial

— TAP ALIF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002217
• Other study ID #: 2022-A00970-43
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Clinique Saint Jean, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fusion of Spine, Lumbar Region

Intervention

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

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

Locations

Country	Name	City	State
France	Clinique St jean sud de france	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint Jean, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic consumption	The use of analgesics (oral or venous) during the during the 72 hours following surgery	72hours
Secondary	Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10	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