Liposomal Bupivacaine for Pain After Lumbar Fusion

Min Li

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Acute Pain; Lumbar Degenerative Diseases

Treatments: Drug: Liposomal bupivacaine (local infiltration); Drug: ropivacaine (local infiltration)

Study type: Interventional

Funder types: Other

Identifiers

NCT07171125

M20250040

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups

Liposomal Bupivacaine Group

Experimental group

Description:

266 mg liposomal bupivacaine + 25 mg bupivacaine HCl, local infiltration during closure

Treatment:

Drug: Liposomal bupivacaine (local infiltration)

Ropivacaine Group

Active Comparator group

Description:

120 mg ropivacaine, local infiltration during closure.

Treatment:

Drug: ropivacaine (local infiltration)