Liposomal Bupivacaine for Pain After Lumbar Fusion
Liposomal Bupivacaine for Acute Pain Management Following Posterior Lumbar Decompression and Fusion Surgery in Adults: A Prospective, Randomized Controlled Trial
Min Li
204 participants
Sep 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria8
- 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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Interventions
Patients will receive a pre-closure local infiltration of 266 mg liposomal bupivacaine (20 mL for single-level surgery; 30 mL for two-level surgery) combined with 25 mg bupivacaine hydrochloride (10 mL total volume). The drug will be injected bilateral into the paraspinal muscles and subcutaneous tissues prior to wound closure. This provides both immediate (bupivacaine HCl) and prolonged (liposomal) analgesia."
Patients will receive 120 mg ropivacaine diluted to 30 mL (single-level) or 40 mL (two-level) with normal saline. The solution will be infiltrated bilateral into the paraspinal muscles and subcutaneous tissues using the same technique as the experimental arm, ensuring consistent injection depth and distribution.
Locations(1)
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NCT07171125