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NCT07895368
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
Conditions: Single-level Lumbar Arthrodesis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Location: Clinique BELHARRA, 2 allée du Dr Robert Lafon Bayonne
Summary
The hypothesis of this study is that intraoperative intravenous lidocaine infusion provides postoperative analgesia and opioid-sparing effects that are at least equivalent to those achieved with a bilateral erector spinae plane block, while offering a simpler and faster procedure that does not require ultrasound guidance and whose efficacy is not dependent on operator expertise or on the uncertain spread of local anesthetic injection in the lumbar region.
Eligibility Criteria
Inclusion Criteria:
* Male or female patients aged ≥18 years.
* Patients who have read, understood, and signed the informed consent form prior to any study-specific procedure.
* Patients scheduled to undergo a single-level posterior lumbar fusion for lumbar spinal stenosis, degenerative spondylolisthesis, or unstable degenerative disc disease.
* Body weight between 50 and 120 kg.
* ASA physical status classification ≤ III.
Exclusion Criteria:
* Emergency surgery.
* Reoperation of the surgical site.
* Contraindication to local anesthetics.
* Contraindication to NSAIDs.
* Coagulation disorder.
* Severe chronic renal or hepatic impairment.
* Patients under legal protection.
* Lack of affiliation with the French social security system.
* Participation in another interventional clinical study that could interfere with the evaluation of analgesic treatments or interpretation of the study outcomes.
* Pregnant or breastfeeding women.
* Women of childbearing potential not using an effective method of contraception.
* Inability to understand study-related information or provide written informed consent.
Source: ClinicalTrials.gov (NCT07895368). StuddyBuddy aggregates publicly available trial information.