Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
2026年8月27日 更新者：Qing-he Zhou、Affiliated Hospital of Jiaxing University
This study aims to evaluate whether 15ml/75mg low-dose bupivacaine liposome is non-inferior to 15ml/133mg standard-dose bupivacaine liposome for postoperative analgesia in interscalene brachial plexus block during arthroscopic shoulder surgery, through a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial.
It will also assess whether 15ml/75mg low-dose bupivacaine liposome is superior to 15ml/133mg standard-dose bupivacaine liposome in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions during interscalene brachial plexus block.
研究概览
地位
邀请报名
详细说明
This study is designed as a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial, to evaluate and compare whether the postoperative analgesic efficacy of 15 mL/75 mg low-dose liposomal bupivacaine for interscalene brachial plexus block in patients undergoing shoulder arthroscopy is non-inferior to that of 15 mL/133 mg standard-dose liposomal bupivacaine, and to further assess whether the low-dose regimen demonstrates advantages over the standard-dose counterpart in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions.
研究类型
介入性
注册 (估计的)
40
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。
学习地点
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Zhejiang
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Jiaxing、Zhejiang、中国、314000
- Jiaxing University Affiliated Hospital
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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 aged 18 years or older.
- ASA classification I-III.
- Arthroscopic shoulder rotator cuff repair, capsular plication, acromioplasty, synovectomy, etc.
Exclusion Criteria:
- Have a history of lung disease.
- Coagulation dysfunction or coagulopathy.
- History of allergy to local anesthetics.
- infection or lesions at the block site; or history of cervical spine disease.
- pregnancy.
- Refusal to participate in the study or inability to communicate.
- Long-term use of opioids.
- Body mass index >35 kg/m2
- Previous history of nerve injury, paralysis, or paresis;
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：OBV bupivacaine liposome group
Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg.
This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
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Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg.
This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
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实验性的：Standard dose bupivacaine liposome group
Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene brachial plexus block prior to surgical incision.
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Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene
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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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Difference in numeric rating scale scores for resting pain at 24 hours after surgery
大体时间：postoperative 24 hours
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Difference in numeric rating scale scores(0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) for resting pain at 24 hours after surgery.
Postoperatively, the NRS scale was used to evaluate pain scores.
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postoperative 24 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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Total consumption of morphine milligram equivalents within 72 hours postoperatively
大体时间：within 72 hours postoperatively
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Record opioid analgesics within 72 hours postoperatively, convert to morphine equivalent dose, and calculate the total amount.
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within 72 hours postoperatively
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Differences in numeric rating scale pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
大体时间：postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
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Differences in numeric rating scale (0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Postoperatively, the NRS scoring scale was used to assess pain scores.
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postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
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Complete unilateral HDP during quiet breathing at 0.5 hours 6 hours, and 24 hours after completion of block
大体时间：postoperative 0.5 hours, 6 hours and 24 hours
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A diaphragm excursion of >75% on the blocked side measured under ultrasound is defined as complete unilateral hemidiaphragmatic paralysis (HDP).
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postoperative 0.5 hours, 6 hours and 24 hours
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Pulmonary function
大体时间：postoperative 0.5 hours, 6 hours and 24 hours
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Use a portable respiratory function tester for bedside testing; have the patient blow three times and take the average.
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postoperative 0.5 hours, 6 hours and 24 hours
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All adverse events related to surgery and anesthesia occurring within 72 hours postoperatively
大体时间：within 72 hours postoperatively
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Adverse events associated with nerve blocks within 72 hours postoperatively, including pneumothorax, intravascular injection, local anesthetic toxicity, and Horner syndrome, were recorded.
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within 72 hours postoperatively
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The number of rescue analgesic interventions required within 72 hours postoperatively
大体时间：within 72 hours postoperatively
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The number of analgesic administrations within the first 72 hours postoperatively was recorded.
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within 72 hours postoperatively
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sensorimotor score
大体时间：postoperative 0.5 hours, 6 hours and 24 hours
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After completion of the block, the simplified sensorimotor assessment scale (3-point method) is used for evaluation, and a total sensorimotor score ≥12 points with a total sensory score ≥3 points is defined as successful brachial plexus block.
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postoperative 0.5 hours, 6 hours and 24 hours
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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9月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年8月23日
首先提交符合 QC 标准的
2026年8月27日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8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.