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RECRUITING
NCT07171125
PHASE4

Liposomal Bupivacaine for Pain After Lumbar Fusion

Sponsor: Min Li

View on ClinicalTrials.gov

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.

Official title: Liposomal Bupivacaine for Acute Pain Management Following Posterior Lumbar Decompression and Fusion Surgery in Adults: A Prospective, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2025-09-20

Completion Date

2026-12-31

Last Updated

2025-09-25

Healthy Volunteers

No

Interventions

DRUG

Liposomal 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."

DRUG

ropivacaine (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.

Locations (1)

Peking University Third Hospital

Beijing, China