Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- The incidence of chronic postoperative pain
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.
详细描述
Researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.Participants will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
- •Participants were 18 years or older.
- •18 kg/m2≤BMI≤30 kg/m2
- •Participants with American Society of Anesthesiology (ASA) physical status I-III.
- •Understand the significance, possible benefits, potential risks of the trial in detail.Understand the procedures and methods of this study.Willing to complete the trial in strict compliance with the clinical trial protocol.Sign the informed consent form voluntarily.
排除标准
- •with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), New York Heart Association (NYHA) functional class III/IV,Ischemic stroke.
- •with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment.
- •with sensory disorders such as hyperalgesia.
- •with other bodily pain.
- •allergy to amide-type local anesthetics or any of the trial drugs
- •taking drugs that affect liver metabolism,corticosteroids,benzodiazepines,non-steroidal anti-inflammatory drugs(NSAIDs),opioid agonist-antagonist,central-alpha 2-agonists,anticonvulsants,antidepressants within 72h.
- •with a history of alcohol or opioid abuse.
- •who were pregnant or lactating.
- •who were currently included in another clinical study within 3 months.
研究组 & 干预措施
intervention (liposomal bupivacaine）
Participants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery.
干预措施: Liposomal bupivacaine (Drug)
control (bupivacaine hydrochloride)
Participants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
The incidence of chronic postoperative pain
时间窗: postoperative day (POD) 90
The incidence of chronic postoperative pain at 90 days
Area under the movement-evoked pain intensity-time curve
时间窗: from 0-72 hours after the intervention
Area under the pain intensity-time curve in the movement (or coughing) state within 72h after the intervention.
次要结局
- Area under the rest pain intensity-time curve(from 0-72 hours after the intervention)
- Movement-evoked pain score(30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention)
- Proportion of participants who did not use rescue analgesia(from 0-72 hours after the intervention)
- Score of satisfaction with analgesia(At 72 hours after the intervention)
- The cumulative dosage of rescue analgesia(from 0-72 hours after the intervention)
- Length of hospital stay(From date of surgery until the date of first hospital discharge，assessed up to 1 months)
- Chronic pain score(postoperative day (POD) 90)
- Pain score at rest(30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention)
- The time of first use of rescue analgesia(from 0-72 hours after the intervention)
- First time out-of-bed(From date of surgery until the date of first out-of-bed，assessed up to 7 days)