The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study
The goal of this clinical trial is to evaluate the efficacy and safety of liposomal bupivacaine for postoperative analgesia in adult patients undergoing lung transplantation. The main questions it aims to answer are:
Does liposomal bupivacaine reduce postoperative opioid consumption after lung transplantation? Does liposomal bupivacaine relieve postoperative pain without increasing adverse events?
Researchers will compare patients receiving liposomal bupivacaine combined with bupivacaine hydrochloride with patients receiving bupivacaine hydrochloride alone to see whether liposomal bupivacaine provides better postoperative analgesia and reduces opioid requirements after lung transplantation.
Participants will:
Receive lung transplantation under standard perioperative care. Receive intercostal nerve block with either liposomal bupivacaine combined with bupivacaine hydrochloride or bupivacaine hydrochloride alone.
Be assessed for postoperative opioid consumption, pain scores, recovery-related outcomes, and adverse events after surgery.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Min Yan
- 电话号码：13757118632
- 邮箱：zryanmin@zju.edu.cn
学习地点
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-
Zhejiang
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Hangzhou、Zhejiang、中国、310000
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
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接触：
- Min Yan
- 电话号码：13757118632
- 邮箱：zryanmin@zju.edu.cn
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients with end-stage lung disease undergoing bilateral lung transplantation; Age >18 years; Expected discontinuation of mechanical ventilation within 48 hours after surgery; The patient or legally authorized representative signs the informed consent form and agrees to participate in the study and follow-up.
Exclusion Criteria:
- Body mass index ≤18 kg/m² or ≥35 kg/m²; Allergy or contraindication to local anesthetics; Preoperative tracheal intubation or requirement for extracorporeal life support; Expected use of other types of nerve block; Active systemic infection or infection at the planned block site; Severe hepatic insufficiency; Severe renal impairment; Chronic pain, neuropathic pain, long-term use of analgesics, or use of other psychotropic medications; Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric disorders; Severe coagulation dysfunction; Concomitant surgery during the same operative session; Pregnant or breastfeeding women.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：liposomal bupivacaine group
Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride after surgery.
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Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
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|
有源比较器：control group
Patients will receive an intercostal nerve block with bupivacaine hydrochloride after surgery.
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Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Opioid consumption within 72 hours after surgery
大体时间：72 hours after surgery
|
72 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ICU住院时间
大体时间：90天内
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90天内
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|
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VAS pain scores
大体时间：at 24 hours, 48 hours, 72 hours, and 1 week after surgery;
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ranging from 0 to 100 mm, with 0 indicating no pain and 100 indicating the worst imaginable pain.
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at 24 hours, 48 hours, 72 hours, and 1 week after surgery;
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Area under the curve of VAS pain scores
大体时间：within 72 hours and 1 week after surgery
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within 72 hours and 1 week after surgery
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Quality of recovery
大体时间：within 1 week after surgery
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assessed using the QoR-15 scale
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within 1 week after surgery
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Sleep quality within 1 week after surgery
大体时间：within 1 week after surgery
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assessed using the Insomnia Severity Index (ISI)
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within 1 week after surgery
|
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Anxiety and depression
大体时间：within 1 week after surgery
|
Anxiety and depression symptoms were assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD), respectively, with HAMA ranging from 0 to 56 and HAMD ranging from 0 to 52.
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within 1 week after surgery
|
|
total hospital stay
大体时间：within 90 days
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within 90 days
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Incidence of chronic pain
大体时间：at 3 months after surgery
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Chronic pain was defined as the incidence of pain 3 months post-surgery, assessed using the VAS score.
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at 3 months after surgery
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sleep quality
大体时间：at 3 months after surgery
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Sleep quality was assessed using the Insomnia Severity Index.
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at 3 months after surgery
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anxiety and depression
大体时间：at 3 months after surgery
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assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD);
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at 3 months after surgery
|
|
quality of recovery
大体时间：at 3 months after surgery
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ssessed using the QoR-15 scale
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at 3 months after surgery
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Incidence of adverse events
大体时间：within 90 days
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including nausea, vomiting, dizziness, infection, pneumothorax, and other complications.
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within 90 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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