Efficacy of Liposomal Bupivacaine Versus Conventional Bupivacaine for Pain Control in Patients Undergoing Laparoscopic Radical Nephrectomy: A Pilot Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery
研究概览
简要总结
The goal of this pilot study is to test the hypothesis that liposomal bupivacaine extends the duration of paravertebral block in patients undergoing radical nephrectomy, achieving improved analgesia compared to conventional bupivacaine. The main questions it aims to answer are:
- Area under curve of numeric rating scale of pain from 12 to 72 h after surgery.
- Cumulative opioid consumption during the period of 12 to 72 h after surgery.
详细描述
Random numbers will be generated by an independent biostatistician in a 1:1 ratio, sealed in sequentially numbered opaque envelopes, and stored by a study coordinator. Only anesthesiologists who perform paravertebral block know group allocation but are not involved in other parts of the trial. Patients, other health-care team members, and investigators for data collection and outcome assessment are masked from group assignments.
Paravertebral block will be performed with either liposomal bupivacaine or plain bupivacaine. The efficacy of nerve block will be assessed every 5 minutes after local anesthetic injection. We will evaluate pain severity, opioid consumption, and occurrence of adverse events at the following timepoints, i.e., end of surgery, 30 minutes after surgery, and 2, 6, 12, 24, 36, 48, 60, and 72 hours after surgery. Additionally, occurrence of complications, quality of recovery, and subjective sleep quality will be assessed during hospital stay after surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years old.
- •Scheduled for laparoscopic-assisted unilateral radical nephrectomy.
- •Agree to undergo regional nerve blockade and receive patient-controlled intravenous analgesia after surgery.
排除标准
- •Renal cancer with venous thrombus of grade II or higher, or cases that may convert to open surgery.
- •Body mass index ≥30 kg/m² or ≤15 kg/m².
- •Severe renal dysfunction (serum creatinine >442 μmol/L or requiring renal replacement therapy), severe liver dysfunction (Child-Pugh class C), or American Society of Anesthesiologists class ≥IV.
- •Contraindications for deep nerve block, including severe spinal deformity or history of spinal surgery, severe coagulation abnormalities (international normalized ratio >1.7, activated partial thromboplastin time >4 seconds above normal, platelet count <80×10⁹/L), trauma or infection at the planned puncture site, or severe lumbar back pain.
- •Chronic opioid dependence and long-term use of various analgesics for more than 3 months.
- •Preoperative inability to communicate due to severe dementia, language barriers, or end-stage diseases.
- •Preoperative concomitant central nervous system and/or peripheral nervous system diseases.
- •Planned endotracheal intubation and admission to the intensive care unit after surgery.
- •Known allergy to local anesthetics.
- •Other conditions that are deemed unsuitable for trial participation by the attending surgeons or investigators.
研究组 & 干预措施
Lipo-bupivacaine
Paravertebral block is performed with liposomal bupivacaine.
干预措施: Performing paravertebral nerve block with lipo-bupivacaine (Drug)
Bupivacaine
Paravertebral block is performed with bupivacaine.
干预措施: Performing paravertebral nerve block with bupivacaine (Drug)
结局指标
主要结局
A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery
时间窗: Between 12 and 72 hours afer surgery
The composite index of pain intensity and opioid consumption (PIOC) will be calculated using the area under curve (AUC) of pain intensity and cumulative opioid consumption between 12 and 72 hours in the postoperative period.
次要结局
- Time to onset after paravertebral block(From end of nerve block to initiation of surgery.)
- Time to maximal block after paravertebral block(From end of nerve block to initiation of surgery.)
- Paravertebral block-related adverse events.(From end of nerve block to initiation of surgery.)
- Extent of paravertebral block(From end of nerve block to 72 hours after surgery.)
- Pain intensity within 72 hours after surgery(Up to 72 hours after surgery)
- A composite index of pain intensity and opioid consumption (PIOC) within 72 hours after surgery.(Up to 72 hours after surgery)
- Cumulative opioid consumption within 72 hours after surgery.(Up to 72 hours after surgery)
研究者
Dong-Xin Wang
Professor
Peking University First Hospital