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Liposomal Bupivacaine for Pain After Lumbar Fusion

NCT07171125 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Postoperative Acute Pain
  • Lumbar Degenerative Diseases

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.

Sponsors & Collaborators

  • Min Li

    lead OTHER

Principal Investigators

  • Min Li · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07171125 on ClinicalTrials.gov