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Completed

NCT Number: NCT07171125

Liposomal Bupivacaine for Pain After Lumbar Fusion

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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Key information

Conditions

Postoperative Acute Pain Lumbar Degenerative Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Third Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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."

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.

Primary outcomes

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

    Time frame: 72 hours postoperative

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

Secondary outcomes

  1. 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.

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

    NRS ranges from 0 (no pain) to 10 (worst imaginable pain). Movement-associated pain will be assessed during standardized activities (e.g., coughing on command or first ambulation).All assessors will be trained to ensure consistent NRS measurement across timepoints.

    Daytime assessments: Performed within ±30 minutes of scheduled timepoints

    Nighttime adjustments:

    Assessments falling between 21:00 (9:00 PM) and 07:00 (7:00 AM) will be deferred to 08:00 AM the following morning to avoid sleep disruption.

    Original timepoints documented with annotations (e.g., "Scheduled: 02:00; Assessed: 08:00+1")

  2. Total postoperative morphine consumption via PCA

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

    PCA settings will be standardized across all patients:

    • Bolus dose: 1 mg morphine equivalent
    • Lockout interval:10 minutes
    • No background infusion.

  3. Total Postoperative Rescue Tramadol Consumption

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

    Trigger Criteria: NRS >3 at rest despite PCA morphine (1mg bolus, 10min lockout).

    Dosing Protocol: Tramadol 50mg IV/oral

    Data Collection:

    Cumulative tramadol consumption recorded at 4hours, 8hour, 24hours, 48hours, 72hours after surgery.

    Convert oral to IV equivalent for analysis

  4. Sleep disturbance due to pain (binary scale)

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

    Patients will report whether pain interfered with sleep during the previous night using a standardized binary scale:

    • 0: No sleep disruption (pain did not awaken or prevent sleep)
    • 1: Sleep disrupted (pain caused awakening or difficulty falling asleep).

    Assessment Protocol:

    Evaluated each morning at 8:00 AM by trained research staff Covers sleep quality during the preceding night (20:00-07:59) Delayed assessment for nighttime surgeries: If surgery ends after 18:00, first assessment deferred to 8:00 AM on postoperative Day 1

  5. Time to first independent ambulation

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

    Definition: Hours from surgery end to first unassisted walking >5 meters

  6. Immediate local anesthetic-related complications (0-2 hours)

    Time frame: From local anesthetic infiltration completion through 2 hours post-procedure.

    All complications will be recorded and graded. Immediate events (0-2h):

    • Local anesthetic systemic toxicity (LAST): CNS/CV symptoms (e.g., seizures, arrhythmias)
    • Allergic reactions: urticaria, bronchospasm, anaphylaxis

  7. Incidence of nausea/vomiting (PONV)

    Time frame: From surgery completion through 72 hours (Day 3) postoperatively, with interval reporting: 0-24 hours (Day 1), 24-48 hours (Day 2), 48-72 hours (Day 3).

    Graded by severity: 1=Mild (no rescue), 2=Moderate (required 1 antiemetic), 3=Severe (≥2 antiemetics or prolonged NPO).

    Standardized Assessment Protocol at fixed timepoints:

    Day 1: 0-24 hours postoperatively Day 2: 24-48 hours postoperatively Day 3: 48-72 hours postoperatively

    Assessment window:

    Performed daily at 08:00 AM for previous 24-hour period Evening surgeries (end time >18:00): First assessment at 08:00 AM on Day 1

    Symptom tracking:

    Nursing staff document all emetic episodes and antiemetic administrations in real-time

  8. Pruritus severity

    Time frame: From surgery completion through 72 hours (Day 3) postoperatively, with interval analyses: 0-24 hours (Day 1)，24-48 hours (Day 2)，48-72 hours (Day 3)

    Rated by patients: 0=None, 1=Mild (no treatment), 2=Moderate (topical therapy), 3=Severe (systemic treatment).

  9. Incidence of Postoperative Urinary Retention Requiring Catheterization

    Time frame: From surgery completion through 72 hours (Day 3) postoperatively, with planned intervals: 0-24 hours (Day 1), 24-48 hours (Day 2), 48-72 hours (Day 3).

    Definition & Assessment Protocol:

    Diagnostic Criteria: Bladder volume ≥600 mL (ultrasound-confirmed) + inability to void spontaneously.

    Catheterization threshold: Pain (VAS ≥4) with bladder volume ≥600 mL, OR No voiding for 8 hours + bladder volume ≥400 mL.

    Data Collection:

    Event-driven assessments: Triggered by patient-reported symptoms. Maximum observation period: 72 hours (Day 3).

  10. Postoperative Sedation Levels Assessed by Ramsay Scale

    Time frame: From anesthesia emergence until 72 hours postoperatively, at Fixed timepoints: 4 hours, 8 hours, 24 hours, 48 hours and 72 hours after surgery.

    Ramsay Scale:

    • Patient anxious/agitated
    • Cooperative/oriented
    • Responds to commands only
    • Asleep but brisk response to stimulus
    • Sluggish response
    • No response.

    Scoring Direction: Higher scores indicate deeper sedation (1=inadequate, 6=excessive).

    Clinical Thresholds:

    Target range: RSS 2-4 (ERAS-recommended optimal sedation) Intervention triggers: RSS ≥5 (reduce sedation), RSS ≤1 (rescue analgesia)

    Assessment Protocol

    Fixed Timepoints:

    4 hours (Postoperative Day 0) 8 hours (Postoperative Day 0) 24 hours (Postoperative Day 1) 48 hours (Postoperative Day 2) 72 hours (Postoperative Day 3)

    Nighttime Adjustment:

    Assessments between 21:00-07:00 deferred to 08:00 next morning Data Collection Window: ±30 minutes at each timepoint

    Standardized Stimuli:

    Verbal: "Open your eyes" at 70 dB Tactile: Shoulder shaking with 500g pressure

  11. Incidence of Postoperative Delirium Assessed by 3D-CAM (3-Minute Diagnostic Interview for CAM-Defined Delirium)

    Time frame: From anesthesia emergence through 72 hours postoperatively: Primary Assessment Points: 24 hours (Postoperative Day 1) 48 hours (Postoperative Day 2) 72 hours (Postoperative Day 3)

    3D-CAM assesses: 1) Acute onset, 2) Inattention, 3) Disorganized thinking, 4) Altered consciousness. Administered by trained research assistants blinded to group allocation.

    Primary Assessment Points:

    24 hours (Postoperative Day 1) 48 hours (Postoperative Day 2) 72 hours (Postoperative Day 3)

    Evaluation Window:

    ± 30 min at each timepoint. Nighttime detections (21:00-07:00) formally assessed at 08:00 next morning

  12. PCA demand attempts

    Time frame: Counted over consecutive intervals: 0-4 hours, 4-8 hours, 8-24 hours, 24-48 hours, and 48-72 hours postoperatively

    Unit of Measure: Number of attempts

  13. PCA delivery/demand ratio

    Time frame: Calculated for each interval: 0-4hours, 4-8hours, 8-24hours, 24-48hhours, 48-72hours after surgery.

    Calculation: (Number of successful PCA deliveries / Number of PCA demand attempts) × 100

  14. Time to first PCA attempt

    Time frame: Recorded from end of surgery until first PCA button press

  15. Time to first tolerated oral intake

    Time frame: From PACU discharge until event occurs, assessed up to 48 hours postoperatively

    Definition: Hours from surgery end to first clear liquid intake (≥50 mL) without vomiting within 30 minutes

  16. Time to first bowel movement

    Time frame: From surgery completion until event occurs, assessed up to 7 days postoperatively

    Definition: Hours from surgery end to first flatus or defecation reported by patient

  17. Postoperative length of stay

    Time frame: From surgery completion until discharge, assessed up to 14 days postoperatively

    Definition: Days from surgery end to hospital discharge (excluding preoperative days)

  18. Delayed local anesthetic-related complications (24-72 hours)

    Time frame: Any clinical suspicion triggers immediate evaluation from 24 hours (Day 1) through 72 hours (Day 3) postoperatively

    Definition: Complications manifesting 24-72 hours postoperatively

    Subcategories:

    1.Wound Complications:

    • Infection: CDC criteria (purulent drainage + ≥1: erythema, pain, swelling)
    • Hematoma: Ultrasound-confirmed collection >5 mL + hemoglobin drop ≥1 g/dL
    • Neurological Injury 2.Persistent deficit: Sensory/motor dysfunction beyond 72 hours Confirmed by: Day 3: Nerve conduction studies (amplitude reduction >50%). Day 7: EMG if symptoms persist

    Assessment Schedule:

    Fixed timepoints: 24h (Day 1), 48h (Day 2), 72h (Day 3) at 08:00 AM Symptom-driven: Any clinical suspicion triggers immediate evaluation

Sponsors and collaborators

Lead sponsor

Min Li

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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