Status:
RECRUITING
Liposomal Bupivacaine for Pain After Lumbar Fusion
Lead Sponsor:
Min Li
Conditions:
Postoperative Acute Pain
Lumbar Degenerative Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 bupivacain...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT07171125
Start Date
September 20 2025
End Date
December 31 2026
Last Update
September 25 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China