Comparing pain relief methods for lumbar spine surgery
Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF): Randomized, Double-blind, Controlled Trial.
This study is testing if a special pain relief method using a TAP block can help people who have had lumbar spine surgery need less pain medication afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Saint Jean, France Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06002217 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of a transverse abdominal plane (TAP) block using levobupivacaine compared to a placebo in patients undergoing anterior lumbar spine surgery. Participants will be randomly assigned to receive either the TAP block or a placebo, and their postoperative pain medication usage will be monitored over a three-day period. The primary goal is to determine if the TAP block can significantly reduce the need for pain medication after surgery.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old scheduled for abdominal disc surgery with ASA criteria 1, 2, or 3.
Not a fit: Patients with allergies to local anesthetics or those undergoing cancer or trauma surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced reliance on opioids after lumbar spine surgery.
How similar studies have performed: Previous studies have shown promising results with TAP blocks in various surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montpellier
- Clinique St jean sud de france — Montpellier, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.