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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine Group | Experimental | 266 mg liposomal bupivacaine + 25 mg bupivacaine HCl, local infiltration during closure |
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| Ropivacaine Group | Active Comparator | 120 mg ropivacaine, local infiltration during closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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") |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Li | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
Individual participant data will not be shared publicly due to local data protection regulations, but anonymized aggregate results will be published.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
|
| 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. |
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| Immediately prior to PACU discharge，4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery. |
| Total postoperative morphine consumption via PCA | PCA settings will be standardized across all patients:
| Cumulative consumption recorded at 4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery |
| Total Postoperative Rescue Tramadol Consumption | 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 | 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) | Patients will report whether pain interfered with sleep during the previous night using a standardized binary scale:
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 | 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 | Definition: Hours from surgery end to first unassisted walking >5 meters | From surgery completion until event occurs, assessed up to 72 hours postoperatively |
| Immediate local anesthetic-related complications (0-2 hours) | All complications will be recorded and graded. Immediate events (0-2h):
| From local anesthetic infiltration completion through 2 hours post-procedure. |
| Incidence of nausea/vomiting (PONV) | 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 | 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). |
| Pruritus severity | Rated by patients: 0=None, 1=Mild (no treatment), 2=Moderate (topical therapy), 3=Severe (systemic treatment). | 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) |
| Incidence of Postoperative Urinary Retention Requiring Catheterization | 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). | 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). |
| Postoperative Sedation Levels Assessed by Ramsay Scale | Ramsay Scale:
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 | From anesthesia emergence until 72 hours postoperatively, at Fixed timepoints: 4 hours, 8 hours, 24 hours, 48 hours and 72 hours after surgery. |
| Incidence of Postoperative Delirium Assessed by 3D-CAM (3-Minute Diagnostic Interview for CAM-Defined Delirium) | 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 | 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) |
| PCA demand attempts | Unit of Measure: Number of attempts | Counted over consecutive intervals: 0-4 hours, 4-8 hours, 8-24 hours, 24-48 hours, and 48-72 hours postoperatively |
| PCA delivery/demand ratio | Calculation: (Number of successful PCA deliveries / Number of PCA demand attempts) × 100 | Calculated for each interval: 0-4hours, 4-8hours, 8-24hours, 24-48hhours, 48-72hours after surgery. |
| Time to first PCA attempt | Recorded from end of surgery until first PCA button press |
| Time to first tolerated oral intake | Definition: Hours from surgery end to first clear liquid intake (≥50 mL) without vomiting within 30 minutes | From PACU discharge until event occurs, assessed up to 48 hours postoperatively |
| Time to first bowel movement | Definition: Hours from surgery end to first flatus or defecation reported by patient | From surgery completion until event occurs, assessed up to 7 days postoperatively |
| Postoperative length of stay | Definition: Days from surgery end to hospital discharge (excluding preoperative days) | From surgery completion until discharge, assessed up to 14 days postoperatively |
| Delayed local anesthetic-related complications (24-72 hours) | Definition: Complications manifesting 24-72 hours postoperatively Subcategories: 1.Wound Complications:
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 | Any clinical suspicion triggers immediate evaluation from 24 hours (Day 1) through 72 hours (Day 3) postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |