Liposomal Bupivacaine for Pain After Lumbar Fusion (NCT07171125) | Clinical Trial Compass
CompletedPhase 4
Liposomal Bupivacaine for Pain After Lumbar Fusion
China204 participantsStarted 2025-09-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total opioid consumption within 72 hours postoperatively (converted to morphine milligram equivalents, MME)