RecruitingPhase 4NCT07171125

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

Sponsor

Min Li

Enrollment

204 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative acute pain Lumbar Degenerative Diseases

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Liposomal bupivacaine (local infiltration) and a drug called ropivacaine (local infiltration) for people with lumbar degenerative diseases and postoperative acute pain. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiposomal bupivacaine (local infiltration)

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."

DRUGropivacaine (local infiltration)

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.