The Effect of Liposomal Bupivacaine Erector Spinae Plane Block
The Effect of Liposomal Bupivacaine Erector Spinae Plane Block on Postoperative Pain in Patients Undergoing Open Upper Abdominal Surgery: A Randomized, Controlled, Double-Blind Trial
This is a single-center, randomized, controlled, double-blind clinical trial.
A total of 148 patients undergoing elective open upper abdominal surgery will be included and randomly assigned 1:1 to receive ultrasound-guided erector spinae plane block with liposome bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone.
The primary outcome is the AUC of resting pain scores from 0 to 72 hours postoperatively.
This study aims to evaluate the analgesic efficacy and safety of liposome bupivacaine and provide a long-acting and safe postoperative analgesia strategy.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
148
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhang Liang
- 电话号码：15858281360
- 邮箱：keyanlunli_zheer@163.com
学习地点
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Hangzhou、中国
- The Second Affiliated Hospital, Zhejiang University School of Medicine
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接触：
- Zhang
- 邮箱：keyanlunli_zheer@163.com
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接触：
- Zhang Liang
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients scheduled for elective open upper abdominal surgery, including open liver, gastric and pancreatic surgery.
- Patients receiving general anesthesia with tracheal intubation.
- Aged from 18 to 80 years old.
- Patients with American Society of Anesthesiologists (ASA) physical status class Ⅰ-Ⅲ.
- Patients who can understand the trial content, are willing to strictly follow the clinical research protocol and complete the trial, and voluntarily sign the informed consent form.
Exclusion Criteria:
- Pregnant or lactating women.
- Patients complicated with severe primary diseases of the lung, liver, kidney, cardiovascular system and hematopoietic system.
- Bleeding tendency or coagulation dysfunction, defined as international normalized ratio (INR) ≥ 1.4, activated partial thromboplastin time > 38 s, or platelet count < 80×10⁹/L.
- Patients with aggravated cardiac diseases (complex congenital heart disease, heart failure and valvular disease) or pulmonary insufficiency.
- Skin infection at the puncture site for erector spinae plane block (ESPB).
- Previous history of neurological or psychiatric diseases, with inability to read, understand and communicate.
- Current obstructive or restrictive pulmonary disease.
- Patients with BMI greater than 30 kg/m².
- Drug abuse, long-term regular use of analgesics, or allergy to the study drugs.
- Patients who refuse to provide informed consent.
- Those enrolled in other randomized controlled trials simultaneously or with other conditions unsuitable for participation in this trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Liposomal Bupivacaine Combined Intervention Arm
Patients in this arm receive ultrasound-guided bilateral T7 erector spinae plane block with a mixed solution of liposomal bupivacaine and conventional bupivacaine hydrochloride, for postoperative analgesia after elective open upper abdominal surgery.
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This intervention uses a combination of liposomal bupivacaine and standard bupivacaine hydrochloride for T7 bilateral erector spinae plane block.
The liposomal formulation provides prolonged local analgesic effect, which differentiates it from the control intervention that uses only conventional bupivacaine hydrochloride without long-acting liposomal components.
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有源比较器：Conventional Bupivacaine Single Agent Arm
Patients in this arm receive ultrasound-guided bilateral T7 erector spinae plane block with conventional bupivacaine hydrochloride alone for postoperative analgesia after elective open upper abdominal surgery.
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This intervention adopts single-agent conventional bupivacaine hydrochloride for bilateral T7 erector spinae plane block, without adding liposomal bupivacaine.
It serves as the conventional analgesia regimen and is different from the combined regimen supplemented with long-acting liposomal bupivacaine in the experimental group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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AUC of resting pain score within 0-72 hours after operation
大体时间：Postoperative 0 to 72 hours
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Calculate the area under the curve (AUC) of resting visual analog scale (VAS) pain scores at multiple time points within 0 to 72 hours after open upper abdominal surgery, to comprehensively evaluate the overall postoperative analgesic effect.
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Postoperative 0 to 72 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative adverse reaction incidence
大体时间：Postoperative 0-72 hours
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Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients.
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Postoperative 0-72 hours
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Time to first ambulation
大体时间：Within 7 days after surgery
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Record the time from the end of surgery to the first off-bed ambulation of patients.
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Within 7 days after surgery
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Postoperative hospital stay
大体时间：From the start of surgery to discharge, the average is ten days
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Record the total length of postoperative hospital stay for each patient.
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From the start of surgery to discharge, the average is ten days
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Dynamic VAS pain score at each time point
大体时间：At 2, 6, 12, 24, 48, and 72 hours postoperatively.
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Compare resting and dynamic Visual Analogue Scale (VAS) pain scores between the two groups.
The VAS is a 10-cm scale ranging from 0 to 10, where 0 = no pain and 10 = worst possible pain (higher scores indicate worse outcomes).
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At 2, 6, 12, 24, 48, and 72 hours postoperatively.
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Dynamic VAS pain score at each time point
大体时间：Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)
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Compare resting and dynamic VAS pain scores at postoperative 2h, 6h, 12h, 24h, 48h and 72h between two groups.
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Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年2月1日
研究完成 (估计的)
2027年2月5日
研究注册日期
首次提交
2026年5月24日
首先提交符合 QC 标准的
2026年6月24日
首次发布 (实际的)
2026年6月25日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.