Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia
2026年5月23日 更新者：Hongwei Shi、Nanjing First Hospital, Nanjing Medical University
Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia in Shoulder Surgery: A Multicenter, Randomized Controlled Study
To compare the effects of 1.33% liposomal bupivacaine versus 0.375% bupivacaine hydrochloride for superior trunk block of the interscalene brachial plexus on postoperative diaphragmatic function and analgesic efficacy in shoulder surgery.
研究概览
地位
邀请报名
研究类型
介入性
注册 (估计的)
184
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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Jiangsu
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Nanjing、Jiangsu、中国、210006
- Nanjing First Hospital
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Nanjing、Jiangsu、中国
- Nanjing Gaochun People's Hospital
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Suzhou、Jiangsu、中国
- the First Affiliated Hospital of Soochow University
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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 unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy;
- Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia;
- Patient provides informed consent;
- Age 18-80 years, any gender;
- ASA physical status I-III;
- 18 kg/m² ≤ BMI ≤ 30 kg/m².
Exclusion Criteria:
- Coagulopathy;
- Allergy to local anesthetics;
- Infection at the puncture site;
- History of chronic pain or opioid use;
- Severe respiratory disease;
- Pregnancy;
- Diabetes and peripheral neuropathy;
- Inability to understand assessment scales.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Liposomal Bupivacaine
When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.
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The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve.
The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk.
1.33% Liposomal bupivacaine 10ml was injected.
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有源比较器：Bupivacaine Hydrochloride
When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.
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The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve.
The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk.
0.375% Bupivacaine Hydrochloride 10ml was injected.
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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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The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
大体时间：Before block 、before leaving the PACU after surgery and 24 hours after surgery
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Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms).
Diaphragmatic Function Evaluation[4,5]: A decrease in diaphragmatic excursion amplitude during deep breathing of <25% compared to pre-block is defined as normal diaphragmatic movement.
A decrease of 25%-75% is defined as partial diaphragmatic paralysis.
A decrease of >75% is defined as complete diaphragmatic paralysis.
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Before block 、before leaving the PACU after surgery and 24 hours after surgery
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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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Numeric Rating Scale (NRS) scores during activity and at rest
大体时间：Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
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Pain intensity at the surgical site will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Patients will self-report their pain intensity at rest (Resting NRS) and during active movement (Dynamic NRS)
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Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
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The area under the pain intensity-time curve (PI-AUC)
大体时间：Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
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The Pain Intensity-Area Under the Curve (PI-AUC) will be calculated as a summary measure of overall pain burden over time.
The AUC for each patient will be computed for three consecutive postoperative periods based on the serial NRS scores (both resting and dynamic) collected during those intervals.
A smaller AUC indicates better overall analgesic control during the specified period.
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Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
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Postoperative recovery quality (QoR-15 score)
大体时间：Postoperative days 1, 2, and 3
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Patient-reported recovery quality will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire.
This validated tool evaluates physical comfort, physical independence, psychological support, emotional state, and pain.
Scores range from 0 (extremely poor recovery) to 150 (excellent recovery).
The upward trend of the QoR-15 score signifies a progressive and comprehensive improvement in a patient's postoperative recovery experience across physical, emotional, and functional domains.
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Postoperative days 1, 2, and 3
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Analgesia satisfaction (OBAS score)
大体时间：Postoperative days 1, 2, and 3
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Patient satisfaction with analgesia and its associated side effects will be evaluated using the Overall Benefit of Analgesia Score (OBAS).
The OBAS is a composite score (range 0-28, lower is better) incorporating assessments of pain intensity, nausea/vomiting, dizziness, sedation, itching, and patient satisfaction.
The downward trend of the OBAS score indicates a progressively more favorable balance between analgesic efficacy and the burden of treatment-related side effects, representing an increasing net benefit of the analgesia regimen.
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Postoperative days 1, 2, and 3
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Morphine equivalent consumption
大体时间：Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
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The total consumption of all opioid analgesics administered to the patient (including patient-controlled analgesia and rescue doses).
All opioid doses will be converted to intravenous morphine milligram equivalents (MME) using standard conversion ratios for summation and comparison.
A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
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Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
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The cumulative dosage of rescue analgesic medication (calculated as morphine equivalent in mg)
大体时间：0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
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This refers specifically to the summed dose of supplemental (rescue) opioid analgesics administered upon patient request for breakthrough pain.
The cumulative dose for each period will be calculated and expressed in intravenous morphine milligram equivalents (MME).
A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
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0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
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Telephone follow-up for pain NRS score
大体时间：Postoperative 3 months
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Patients will be contacted by telephone at 3 months after surgery.
They will be asked to self-report their current average pain intensity over the past 24 hours at the surgical site using the 11-point Numeric Rating Scale (NRS, 0-10), where 0 represents "no pain" and 10 represents "the worst pain imaginable."
This assesses the potential long-term impact of the analgesic intervention on persistent postoperative pain.
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Postoperative 3 months
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Incidence of adverse events: Vascular injury, hoarseness, Horner's syndrome, SpO2 below 90% without oxygen supplementation after leaving PACU, dyspnea, numbness of fingers, dyskinesia.
大体时间：Postoperative 72 hours
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Vascular injury: Evidence of hematoma or vascular puncture during needle placement. Hoarseness: Patient-reported or clinician-identified voice change suggestive of recurrent laryngeal nerve involvement. Horner's syndrome: Presence of ptosis, miosis, and/or anhidrosis on the blocked side. Diaphragmatic paralysis: defined by a reduction in diaphragmatic excursion amplitude >25% from baseline on ultrasound assessment performed post-block. SpO2 <90% on room air after PACU discharge: Oxygen saturation falling below 90% while breathing room air, occurring after the patient has been discharged from the PACU, and not related to other obvious causes. Dyspnea: Subjective sensation of shortness of breath or labored breathing. Finger numbness: Persistent numbness or loss of sensation in the fingers of the blocked upper limb. Motor difficulty: Persistent weakness or inability to perform specific voluntary movements in the blocked upper limb. |
Postoperative 72 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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Amaral S, Arsky Lombardi R, Medeiros H, Nogueira A, Gadsden J. Superior Trunk Block Is an Effective Phrenic-Sparing Alternative to Interscalene Block for Shoulder Arthroscopy: A Systematic Review and Meta-Analysis. Cureus. 2023 Nov 3;15(11):e48217. doi: 10.7759/cureus.48217. eCollection 2023 Nov.
- Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
- Wilson TA, Legrand A, Gevenois PA, De Troyer A. Respiratory effects of the external and internal intercostal muscles in humans. J Physiol. 2001 Jan 15;530(Pt 2):319-30. doi: 10.1111/j.1469-7793.2001.0319l.x.
- Hutchins JL, Habeck J, Novaczyk Z, Campbell R, Creedon C, Spartz E, Richter M, Wolter J, Suryawanshi G, Kaizer A, Berg AA. Patient Complications after Interscalene Block: A Retrospective Comparison of Liposomal Bupivacaine to Nonliposomal Bupivacaine. Anesthesiol Res Pract. 2020 Mar 27;2020:6704303. doi: 10.1155/2020/6704303. eCollection 2020.
- Ilfeld BM, Sessler DI. Liposomal Bupivacaine in Peripheral Nerve Blocks: Duration and Meaningful Differences. Anesthesiology. 2024 Oct 1;141(4):638-642. doi: 10.1097/ALN.0000000000005133. No abstract available.
- Chan TCW, Wong JSH, Wang F, Fang CX, Yung CS, Chan MTH, Chan WSH, Wong SSC. Addition of Liposomal Bupivacaine to Standard Bupivacaine versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: A Randomized Controlled Trial. Anesthesiology. 2024 Oct 1;141(4):732-744. doi: 10.1097/ALN.0000000000005035.
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5月6日
初级完成 (估计的)
2027年3月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年5月5日
首先提交符合 QC 标准的
2026年5月12日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月23日
最后验证
2026年5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.
肩关节置换术的临床试验
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University Hospital, Angers招聘中
Liposomal bupivacaine的临床试验
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Pakistan Navy Station Shifa Hospital完全的