Liposomal Bupivacaine for Acute Pain Management Following Posterior Lumbar Decompression and Fusion Surgery in Adults: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Total opioid consumption within 72 hours postoperatively (converted to morphine milligram equivalents, MME)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Liposomal Bupivacaine Group
266 mg liposomal bupivacaine + 25 mg bupivacaine HCl, local infiltration during closure
干预措施: Liposomal bupivacaine (local infiltration) (Drug)
Ropivacaine Group
120 mg ropivacaine, local infiltration during closure.
干预措施: ropivacaine (local infiltration) (Drug)
结局指标
主要结局
Total opioid consumption within 72 hours postoperatively (converted to morphine milligram equivalents, MME)
时间窗: 72 hours postoperative
Opioid doses will be converted to MME using the CDC standard conversion table
次要结局
- 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)
- Immediate local anesthetic-related complications (0-2 hours)(From local anesthetic infiltration completion through 2 hours post-procedure.)
- Incidence of nausea/vomiting (PONV)(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(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(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(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)(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(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(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(From PACU discharge until event occurs, assessed up to 48 hours postoperatively)
- Time to first bowel movement(From surgery completion until event occurs, assessed up to 7 days postoperatively)
- Postoperative length of stay(From surgery completion until discharge, assessed up to 14 days postoperatively)
- Delayed local anesthetic-related complications (24-72 hours)(Any clinical suspicion triggers immediate evaluation from 24 hours (Day 1) through 72 hours (Day 3) postoperatively)
研究者
Min Li
Professor and Chief Physician
Peking University Third Hospital