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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to treatment allocation. Before block placement, participants will receive intravenous midazolam. Both groups will be positioned similarly, and identical dressings will be applied over the posterior shoulder and suprascapular regions after block completion to conceal the injection sites. Outcome assessments will be performed by an investigator who is not involved in block administration and is unaware of treatment allocation. The physician performing the block cannot be blinded because of the procedural differences between the interventions and will not participate in outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Shoulder Posterior Pericapsular Nerve Group (SPENG) Block (Procedure)
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.
干预措施: Combined Posterior Suprascapular and Axillary Nerve Blocks (Procedure)
结局指标
主要结局
Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
时间窗: 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.
次要结局
- Proportion of Participants With Complete Dual-Target Sensory Block Success(30 minutes after block completion)
- Cumulative Opioid Consumption During the First 24 Postoperative Hours(From arrival in the post-anesthesia care unit through 24 hours after surgery)
- Time to First Rescue Analgesic(From block completion through 24 hours after surgery)
- Resting Numeric Rating Scale Pain Scores(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(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(At 8, 12, and 24 hours after surgery)
- Posterior Shoulder Numeric Rating Scale Pain Score(At 8, 12, and 24 hours after surgery)
- Proportion of Participants With Hemidiaphragmatic Paresis(30 minutes after block completion)
- Change in Diaphragmatic Excursion From Baseline(Baseline and 30 minutes after block completion)
- Shoulder Abduction Motor Strength(Baseline, 30 minutes after block completion, and 24 hours after surgery)
- Proportion of Participants With Rebound Pain(During the first 24 postoperative hours)
- Quality of Recovery-15 Score(24 hours after surgery)
- Patient Satisfaction With Perioperative Analgesia(24 hours after surgery)
- Number of Participants With Block-Related Complications(From block performance through postoperative day 7)
- Block Performance Time(Periprocedural)
研究者
Murat Kaykaç
Anesthesiology and Reanimation Specialist
Izmir City Hospital