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Recruiting Phase 4 NCT07171125

Liposomal Bupivacaine for Pain After Lumbar Fusion

Trial Parameters

Condition Postoperative Acute Pain
Sponsor Min Li
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 204
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-20
Completion 2026-12-31
Interventions
Liposomal bupivacaine (local infiltration)ropivacaine (local infiltration)

Brief Summary

Spine surgery often causes severe postoperative pain. Currently, our hospital routinely uses ropivacaine for local infiltration analgesia (lasting 6-8 hours). This study evaluates liposomal bupivacaine, a novel long-acting local anesthetic providing up to 72 hours of pain relief, in patients undergoing posterior lumbar spine surgery. Through a randomized controlled design, we will compare the two drugs' effects on pain control within 72 hours and opioid consumption. Both regimens are guideline-recommended and safe.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years; * ASA physical status class I-III; * Scheduled for elective 1- or 2-level posterior lumbar surgery: Decompression (laminectomy/discectomy) and fusion with internal fixation Exclusion Criteria: * Chronic pain disorders requiring ≥30 mg oral morphine equivalents/day for \>3 months. * Pre-existing neurological deficits that may interfere with pain assessment. * Hypersensitivity to any component of multimodal analgesia or local anesthetics (e.g., bupivacaine, ropivacaine). * Acute systemic/local infection (e.g., surgical site infection, sepsis). * Metastatic spinal malignancies (confirmed by imaging/histopathology). * Pregnancy or lactation. * Patient refusal after detailed protocol explanation. * Other investigator-determined high-risk conditions.

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