Liposomal Bupivacaine for Pain After Lumbar Fusion

NCT07171125 | Recruiting Phase 4 DMC

• 1 other identifier: M20250040
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liposomal bupivacaine; Local infiltration analgesia; Posterior lumbar fusion; Postoperative pain; Randomized controlled trial; Opioid-sparing

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption within 72 hours postoperatively (converted to morphine milligram equivalents, MME)

  Opioid doses will be converted to MME using the CDC standard conversion table

  72 hours postoperative

Secondary Outcomes (18)

• Postoperative pain intensity assessed by Numeric Rating Scale (NRS, 0-10) at rest and during movement (e.g., coughing/ambulation) at predefined timepoints: pre-PACU discharge, 4h, 8h, 24h, 48h, and 72h after surgery.

  Immediately prior to PACU discharge，4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery.

• Total postoperative morphine consumption via PCA

  Cumulative consumption recorded at 4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery

• Total Postoperative Rescue Tramadol Consumption

  From PCA initiation until 72 hours (Day3) postoperatively. Rescue tramadol consumption will be recorded at 4hours, 8hour, 24hours, 48hours, 72hours after surgery.

• Sleep disturbance due to pain (binary scale)

  Postoperative Days 1 (24 hours), 2 (48 hours), and 3 (72 hours), with daily assessment window: 8:00-9:00 AM

• Time to first independent ambulation

  From surgery completion until event occurs, assessed up to 72 hours postoperatively

Study Arms (2)

Liposomal Bupivacaine Group

EXPERIMENTAL

266 mg liposomal bupivacaine + 25 mg bupivacaine HCl, local infiltration during closure

Drug: Liposomal bupivacaine (local infiltration)

Ropivacaine Group

ACTIVE COMPARATOR

120 mg ropivacaine, local infiltration during closure.

Drug: ropivacaine (local infiltration)

Interventions

Liposomal bupivacaine (local infiltration) DRUG

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."

Liposomal Bupivacaine Group

ropivacaine (local infiltration) DRUG

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.

Ropivacaine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min Li: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Min Li

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Li

CONTACT

+8613522757239; liminanesth@bjmu.edu.cn

Wenwen Zhai

CONTACT

+8613811523204; zhaiwenwen_1987@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All personnel responsible for short-term and long-term postoperative follow-up, completion of clinical observation forms, and data entry/verification are excluded from patient recruitment, randomization, and anesthesia management. These personnel remain blinded to patient group allocation and are prohibited from communicating with the study coordinator regarding any group assignment information.Statistical analysis is performed by dedicated statisticians not involved in clinical anesthesia procedures.Both patients and their family members remain blinded to group allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 12, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)