Liposomal Bupivacaine for Pain After Lumbar Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Acute Pain Lumbar Degenerative Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Liposomal Bupivacaine Group

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

Group Type EXPERIMENTAL

Liposomal bupivacaine (local infiltration)

Intervention Type 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."

Ropivacaine Group

120 mg ropivacaine, local infiltration during closure.

Group Type ACTIVE_COMPARATOR

ropivacaine (local infiltration)

Intervention Type 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.

Interventions

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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."

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No