Liposomal bupivacaine versus ropivacaine 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
This trial tests whether a long-acting liposomal bupivacaine injection gives longer pain relief and lowers opioid use compared with ropivacaine for adults having 1- or 2-level posterior lumbar fusion.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07171125 on ClinicalTrials.gov |
What this trial studies
In a randomized, controlled Phase 4 trial at Peking University Third Hospital, adults undergoing elective 1- or 2-level posterior lumbar decompression and fusion are assigned to local wound infiltration with either liposomal bupivacaine or standard ropivacaine. Pain scores over the first 72 hours and postoperative opioid consumption are the key outcomes. Eligible patients are age 18 or older with ASA I-III and without high-dose chronic opioid use, active infection, metastatic spinal disease, or local anesthetic allergy. The trial compares a novel long-acting formulation that can last up to 72 hours against routine short-acting local analgesia to see if it improves early postoperative pain control and reduces opioid requirements.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for elective 1- or 2-level posterior lumbar decompression and fusion, with ASA class I–III and not on high-dose chronic opioids, are the ideal candidates.
Not a fit: Patients with chronic high-dose opioid dependence, active infection, metastatic spinal malignancy, allergy to local anesthetics, pregnancy or lactation are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, liposomal bupivacaine could provide longer-lasting postoperative pain relief and reduce opioid use after lumbar fusion.
How similar studies have performed: Liposomal bupivacaine has shown mixed results across surgical settings with some reductions in early pain and opioid use in nonspine surgeries, while spine-specific evidence remains limited and variable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Min Li — Peking University Third Hospital
- Study coordinator: Min Li
- Email: liminanesth@bjmu.edu.cn
- Phone: +8613522757239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.