SPENG Block Versus Suprascapular and Axillary Nerve Blocks for Pain After Shoulder Arthroscopy (SPENG-RCT)
2026年8月12日 更新者：Murat Kaykaç、Izmir City Hospital
Analgesic Efficacy of the Shoulder Posterior Pericapsular Nerve Group Block Versus Combined Posterior Suprascapular and Axillary Nerve Blocks for Shoulder Arthroscopy: A Randomized, Blinded, Non-Inferiority Trial
This prospective, randomized, patient- and assessor-blinded, single-center non-inferiority trial will compare the analgesic efficacy of the Shoulder Posterior Pericapsular Nerve Group (SPENG) block with combined posterior suprascapular and axillary nerve blocks in adults undergoing elective shoulder arthroscopy under general anesthesia.
Both groups will receive the same total volume and concentration of local anesthetic.
The primary outcome will be the highest resting Numeric Rating Scale pain score recorded during the first 24 postoperative hours.
Secondary outcomes will include block performance time, sensory block success in suprascapular and axillary nerve territories, opioid consumption, time to rescue analgesia, motor function, diaphragmatic function, postoperative recovery quality, patient satisfaction, and block-related complications.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
60
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：Murat KAYKAC, MD
- 电话号码：+905330258450
- 邮箱：drmuratkaykac@gmail.com
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:
- Age 18 to 70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled to undergo elective shoulder arthroscopy under general anesthesia
- Able to understand the Numeric Rating Scale for pain assessment
- Able and willing to provide written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to local anesthetics used in the study
- Infection at the planned block injection site
- Coagulopathy or ongoing anticoagulant therapy that cannot be appropriately interrupted for peripheral nerve block
- Pre-existing neurological deficit affecting the operative upper extremity
- Moderate or severe pulmonary disease
- Known diaphragmatic dysfunction
- Chronic opioid use
- Chronic pain syndrome
- Body mass index greater than 35 kg/m²
- Pregnancy or breastfeeding
- Inability to understand or reliably report Numeric Rating Scale pain scores
- Inadequate sonographic window preventing safe performance of the allocated block technique before randomization
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：SPENG Block
Participants assigned to this group will receive an ultrasound-guided Shoulder Posterior Pericapsular Nerve Group (SPENG) block before general anesthesia for shoulder arthroscopy.
A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered as a single injection between the posterior glenoid rim and the deep surface of the infraspinatus muscle.
|
An ultrasound-guided single-injection posterior pericapsular block.
With the participant in the lateral decubitus position and the operative shoulder uppermost, a high-frequency linear ultrasound transducer will be placed transversely immediately inferior to the posterior acromion.
After identification of the humeral head, articular cartilage, infraspinatus muscle, and posterior glenoid rim, a block needle will be advanced in-plane in a medial-to-lateral direction.
The needle tip will be positioned between the posterior glenoid rim and the deep surface of the infraspinatus muscle, and 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be injected.
其他名称：
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有源比较器：Posterior Suprascapular and Axillary Nerve Blocks
Participants assigned to this group will receive ultrasound-guided posterior suprascapular and axillary nerve blocks before general anesthesia for shoulder arthroscopy.
A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered, consisting of 10 mL for the posterior suprascapular nerve block and 10 mL for the axillary nerve block.
|
wo ultrasound-guided nerve blocks will be performed.
For the posterior suprascapular nerve block, the suprascapular nerve will be identified in the suprascapular notch region beneath the supraspinatus muscle, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered.
For the axillary nerve block, the posterior humeral circumflex artery will be identified using color Doppler in the quadrilateral space, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered adjacent to the axillary nerve.
其他名称：
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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 |
|---|---|---|
|
Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
大体时间：From arrival in the post-anesthesia care unit through 24 hours after surgery
|
Resting postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
For each participant, the highest resting NRS score recorded during the first 24 postoperative hours will be used as the primary outcome.
Scheduled assessments will be performed on arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery.
Resting NRS scores obtained immediately before rescue analgesic administration outside these scheduled assessments will also be included when determining the highest value.
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From arrival in the post-anesthesia care unit through 24 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Participants With Complete Dual-Target Sensory Block Success
大体时间：30 minutes after block completion
|
Cold sensation will be assessed over the posterior shoulder (suprascapular nerve territory) and lateral deltoid region (axillary nerve territory) using a 3-point scale: 0 = absent sensation, 1 = reduced sensation, and 2 = normal sensation.
Suprascapular sensory component success will be defined as a reduction of at least one grade from baseline in the posterior shoulder region.
Axillary sensory component success will be defined as a reduction of at least one grade from baseline in the lateral deltoid region.
Complete dual-target sensory block success will require successful sensory blockade in both territories in the same participant.
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30 minutes after block completion
|
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Cumulative Opioid Consumption During the First 24 Postoperative Hours
大体时间：From arrival in the post-anesthesia care unit through 24 hours after surgery
|
All rescue opioid analgesics administered during the first 24 postoperative hours will be recorded and converted to intravenous morphine-equivalent dose for comparison between groups.
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From arrival in the post-anesthesia care unit through 24 hours after surgery
|
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Time to First Rescue Analgesic
大体时间：From block completion through 24 hours after surgery
|
Time from completion of the study block to the first administration of rescue analgesic medication for postoperative pain.
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From block completion through 24 hours after surgery
|
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Resting Numeric Rating Scale Pain Scores
大体时间：On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
|
Resting pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain).
|
On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
|
|
Numeric Rating Scale Pain Scores With Movement
大体时间：On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
|
Pain intensity during standardized shoulder-related movement will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain), when clinically feasible.
|
On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
|
|
Anterior Shoulder Numeric Rating Scale Pain Score
大体时间：At 8, 12, and 24 hours after surgery
|
Pain localized predominantly to the anterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
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At 8, 12, and 24 hours after surgery
|
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Posterior Shoulder Numeric Rating Scale Pain Score
大体时间：At 8, 12, and 24 hours after surgery
|
Pain localized predominantly to the posterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
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At 8, 12, and 24 hours after surgery
|
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Proportion of Participants With Hemidiaphragmatic Paresis
大体时间：30 minutes after block completion
|
Diaphragmatic excursion will be assessed using M-mode ultrasonography.
Hemidiaphragmatic paresis will be defined as diaphragmatic excursion 30 minutes after block completion falling to less than 25% of the participant's baseline excursion.
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30 minutes after block completion
|
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Change in Diaphragmatic Excursion From Baseline
大体时间：Baseline and 30 minutes after block completion
|
Diaphragmatic excursion will be measured using M-mode ultrasonography as the difference in diaphragm position between resting expiration and deep inspiration.
Three measurements will be obtained and averaged.
Change from baseline will be evaluated after the block.
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Baseline and 30 minutes after block completion
|
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Shoulder Abduction Motor Strength
大体时间：Baseline, 30 minutes after block completion, and 24 hours after surgery
|
Shoulder abduction strength will be evaluated using the Medical Research Council (MRC) scale ranging from 0 to 5, with higher scores indicating greater muscle strength.
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Baseline, 30 minutes after block completion, and 24 hours after surgery
|
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Proportion of Participants With Rebound Pain
大体时间：During the first 24 postoperative hours
|
Rebound pain will be defined as an increase from an NRS pain score of 3 or lower at the preceding assessment to an NRS score of 7 or higher at the subsequent assessment.
|
During the first 24 postoperative hours
|
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Quality of Recovery-15 Score
大体时间：24 hours after surgery
|
Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15).
The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
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24 hours after surgery
|
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Patient Satisfaction With Perioperative Analgesia
大体时间：24 hours after surgery
|
Overall satisfaction with perioperative analgesia will be rated on an 11-point scale from 0 (completely dissatisfied) to 10 (completely satisfied).
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24 hours after surgery
|
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Number of Participants With Block-Related Complications
大体时间：From block performance through postoperative day 7
|
Participants will be assessed for block-related adverse events including hematoma, infection, persistent paresthesia, persistent weakness, and other clinically suspected complications.
|
From block performance through postoperative day 7
|
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Block Performance Time
大体时间：Periprocedural
|
Time required to perform the allocated regional anesthesia technique, measured in seconds from the first contact of the ultrasound transducer with the skin until removal of the block needle after completion of local anesthetic injection.
|
Periprocedural
|
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。
调查人员
- 首席研究员：Murat KAYKAC, MD、İzmir City Hospital
- 研究主任：Derya ARSLAN YURTLU, Professor、İzmir City Hospital
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11月1日
初级完成 (估计的)
2027年5月31日
研究完成 (估计的)
2027年6月15日
研究注册日期
首次提交
2026年8月9日
首先提交符合 QC 标准的
2026年8月9日
首次发布 (实际的)
2026年8月13日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- SPENG-RCT-2026-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request to the principal investigator.
Data will be shared after publication of the main study results, subject to approval of the proposed use and compliance with applicable ethical and institutional data-protection requirements.
IPD 共享时间框架
Beginning after publication of the primary study results and available for 5 years thereafter.
IPD 共享访问标准
Requests from qualified researchers with a scientifically sound proposal will be considered by the principal investigator.
Data will be provided in de-identified form for approved research purposes and subject to applicable institutional and ethical requirements.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.