Comparison of Anterior Suprascapular and Axillary Nerve Block Versus Interscalene Block for Postoperative Analgesia and Diaphragmatic Function in Shoulder Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Postoperative Pain Intensity at Rest
研究概览
简要总结
Shoulder surgeries are among the most frequently performed orthopedic interventions and are often associated with moderate to severe postoperative pain. In these procedures, effective pain management is crucial for early rehabilitation and patient comfort.
Peripheral nerve blockade is widely used for postoperative analgesia in shoulder surgery. While the interscalene brachial plexus block is considered the gold standard for pain control, it is frequently associated with unintended phrenic nerve blockade, leading to hemidiaphragmatic paresis. To minimize respiratory complications while maintaining effective analgesia, alternative diaphragm-sparing regional anesthesia techniques, such as the combination of suprascapular and axillary nerve blocks, have been introduced.
The aim of this study is to compare the analgesic efficacy and respiratory functions preservation of the ultrasound-guided anterior approach suprascapular combined with axillary nerve block versus interscalene block in patients undergoing shoulder surgery
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years
- •American Society of Anesthesiologists (ASA) physical status I, II, or III
- •Patients scheduled to undergo elective arthroscopic shoulder surgery
- •BMI between 18 and 30 kg/m2
- •Ability to provide written informed consent
排除标准
- •Known allergy or hypersensitivity to local anesthetics
- •Presence of localized infection at the planned injection site
- •Severe coagulopathy or active use of anticoagulant medications
- •Contralateral phrenic nerve palsy or a diagnosis of severe chronic obstructive pulmonary disease (COPD)
- •History of chronic opioid consumption or neuropathic pain
研究组 & 干预措施
Interscalene Block
After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely at the level of the cricoid cartilage (C6) with the head turned to the contralateral side. Advancing the needle laterally into the interscalene groove between the anterior and middle scalene muscles, 10 mL of local anesthetic (%0.5 bupivacaine ) will be injected between the C5 and C6 nerve roots.
干预措施: Interscalene Block (Procedure)
Combination of Axillary and Anterior Suprascapular Blocks
After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely in the supraclavicular fossa with the head turned to the contralateral side. Advancing the needle in-plane, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the suprascapular nerve as it branches anteriorly from the superior trunk of the brachial plexus. Subsequently, for the axillary nerve block, the patient will be positioned laterally and the ultrasound probe will be placed longitudinally over the posterior aspect of the shoulder. Advancing the needle into the quadrangular space, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the axillary nerve adjacent to the posterior circumflex humeral artery.
干预措施: Combination of Axillary and Anterior Suprascapular Blocks (Procedure)
结局指标
主要结局
Postoperative Pain Intensity at Rest
时间窗: 4 hours after surgery.
Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 4 hours after surgery.
次要结局
- Postoperative Pain Intensity at Rest(Up to 24 hours)
- Postoperative Pain Intensity at Movement(Up to 24 hours)
- Total Postoperative Opioid Consumption(Up to 24 hours)
- Area Under Curve(At the 24th hour)
- Diaphragmatic Excursion(Baseline (immediately before block performance) and 30 minutes after block performance)
- Forced vital capacity (FVC) (volume)(Perioperative period)
- Forced expiratory flow in 1 s (FEV1) (volume)(Perioperative period)
- FEV1/FVC(Perioperative period)
研究者
İbrahim Topcu
Principal Investigator
Ankara Etlik City Hospital