Randomized Control Study: The Effectiveness of Field Block (Local Anesthesia) Compared With Interscalene Block in Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity measured by Numerical Rating Scale (NRS)
研究概览
简要总结
This study will compare two different types of anesthesia used for shoulder surgery. The first method, called an interscalene block, is commonly performed by anesthesiologists and is effective for pain control but may cause side effects such as breathing problems, arm weakness, or discomfort. The second method, called a shoulder field block, is a newer technique performed by orthopedic surgeons that numbs the nerves around the shoulder without affecting breathing.
Patients scheduled for shoulder surgery will be randomly assigned to receive either the interscalene block or the shoulder field block. The main goal of the study is to find out whether the shoulder field block provides pain relief that is as effective as the interscalene block, but with fewer side effects.
Pain levels, patient satisfaction, length of hospital stay, need for pain medication, and any complications will be recorded and compared between the two groups. The results may help identify a safe and effective alternative anesthesia option for patients undergoing shoulder surgery.
详细描述
Regional anesthesia is widely used for shoulder surgery, most commonly with an interscalene brachial plexus block (ISB). While ISB provides effective pain relief, it is associated with side effects such as hemidiaphragmatic paralysis, breathing difficulties, Horner's syndrome, nerve injury, and rebound pain. These risks limit its use in patients with respiratory conditions, obesity, or other contraindications.
A shoulder field block (FB) is a newer approach that targets the suprascapular, axillary, and lateral pectoral nerves, which supply most of the sensation to the shoulder joint. Unlike ISB, the field block does not affect the phrenic nerve, making it a potentially safer option. Cadaveric and early clinical studies suggest that field blocks may provide effective pain relief with fewer complications, but direct comparisons with ISB in surgical patients are limited.
This randomized controlled trial will enroll 64 adult patients undergoing arthroscopic or open shoulder surgery. Patients will be randomized into two groups:
Field Block Group: Local anesthesia field block performed by an orthopedic surgeon using anatomical landmarks.
Interscalene Block Group: Standard interscalene block performed by an anesthesiologist.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Scheduled for arthroscopic or open shoulder surgery
排除标准
- •Prior surgery or trauma to the shoulder
- •Revision shoulder surgery
- •Fibromyalgia
- •Pregnancy
- •Contraindications to regional anesthesia (e.g., allergy to local anesthetics, coagulopathy, local site infection)
- •Preexisting neuropathy or myopathy of the surgical limb
- •History of chronic opioid use
- •Cognitive impairment or inability to understand pain scoring systems (e.g., dementia)
研究组 & 干预措施
Shoulder Field Block by Orthopedic Surgeon
Participants in this arm will receive a shoulder field block performed by the orthopedic surgeon using anatomical landmarks after induction of general anesthesia. The block targets the suprascapular, axillary, and lateral pectoral nerves using a tumescent local anesthetic mixture of lidocaine with epinephrine, bupivacaine, and saline to provide intraoperative and postoperative analgesia. This novel technique aims to provide effective pain relief with fewer side effects compared to the standard interscalene brachial plexus block.
干预措施: Shoulder Field Block by Orthopedic Surgeon (Procedure)
Interscalene Block by Anesthesiologist
Participants in this arm will receive a standard interscalene brachial plexus block performed by an anesthesiologist under ultrasound guidance before surgery. This block anesthetizes the upper brachial plexus nerves to provide effective intraoperative and postoperative analgesia for shoulder surgery. It is the current standard of care but may be associated with side effects such as diaphragmatic paralysis and arm weakness.
干预措施: Interscalene brachial plexus block and superficial cervical plexus block (Procedure)
结局指标
主要结局
Postoperative pain intensity measured by Numerical Rating Scale (NRS)
时间窗: From 1 hour postoperative until 48 hours after surgery
Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst pain imaginable. Measurements will be taken at 1 hour postoperatively in the Post-Anesthesia Care Unit (PACU), at discharge from PACU, and at 6, 12, 24, and 48 hours after surgery. This outcome evaluates the effectiveness of the Shoulder Field Block compared to the Interscalene Block in controlling postoperative pain.
次要结局
未报告次要终点
研究者
FERAS QAWASMI
Orthopedic Surgeon, Department of Orthopedic Surgery, Hasharon Hospital, Rabin Medical Center
Rabin Medical Center