Comparison of Axillary Block and Interfascial Axillary Block in Terms of Block Success and Intraoperative Clinical Efficacy in Hand, Wrist, and Forearm Surgery: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Surgical anesthesia adequacy (block success)
研究概览
简要总结
Hand, wrist, and forearm surgeries are commonly performed procedures with significant postoperative pain potential. Regional anesthesia of the brachial plexus via the axillary approach is one of the gold-standard techniques for distal upper-limb surgery. In the conventional (classic) axillary block, the median, ulnar, and radial nerves within the axillary sheath are individually targeted under ultrasound guidance; however, anatomical septations around the axillary artery may prevent homogeneous spread of local anesthetic, leading to a patchy block and reduced intraoperative success.
The interfascial axillary block is a modified approach in which local anesthetic is deposited into the fascial planes between the axillary muscles rather than directly into the nerve sheath, aiming for passive diffusion, homogeneous spread, and fewer needle manipulations. This prospective, randomized, single-center study compares the classic axillary block with the interfascial axillary block in patients undergoing hand, wrist, and forearm surgery, primarily in terms of surgical anesthesia adequacy (block success).
详细描述
This is a prospective, randomized, single-center clinical trial conducted in a Department of Anesthesiology and Reanimation. Randomization is performed using the sealed-envelope method. A total of 110 patients (55 per group) aged 18-90 years, American society of anesthesiologists physical status I-III, scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided regional anesthesia will be enrolled.
Group 1 (Classic Axillary Block) receives an ultrasound-guided block targeting the median, ulnar, and radial nerves perineurally/perivascularly within the axillary sheath. Group 2 (Interfascial Axillary Block) receives an ultrasound-guided injection of local anesthetic into the potential fascial planes between the axillary muscles, relying on passive diffusion.
The primary outcome is surgical anesthesia adequacy (block success). Secondary outcomes include block application time, sensory and motor block onset, rates of additional local infiltration and conversion to general anesthesia, intraoperative additional analgesic/sedation requirements, hemodynamic parameters, patient and surgeon satisfaction, and 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
- Single (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
- •Aged 18-90 years
- •American society of anesthesiologists physical status I-II-III
- •Scheduled for elective hand, wrist, or forearm surgery
- •Written informed consent obtained
排除标准
- •History of local anesthetic allergy
- •Coagulation disorder
- •BMI > 40 kg/m²
- •Infection at the block site
- •Chronic pain syndrome
- •Pregnancy
- •Inability to communicate
- •Need for emergency surgery
研究组 & 干预措施
Classic Axillary Block
Ultrasound-guided classic axillary brachial plexus block. The median, ulnar, and radial nerves within the axillary sheath around the axillary artery are targeted individually by perineural/perivascular injection of local anesthetic.
干预措施: Classic Axillary Block (Procedure)
Interfascial Axillary Block
Ultrasound-guided interfascial axillary block. Local anesthetic is injected into the potential fascial planes between the axillary muscles rather than directly into the nerve sheath, allowing passive diffusion of the drug.
干预措施: Interfascial Axillary Block (Procedure)
结局指标
主要结局
Surgical anesthesia adequacy (block success)
时间窗: 30 minutes after block
Complete sensory and motor blockade of the surgical field, allowing the operation to be completed without additional local infiltration or conversion to general anesthesia
次要结局
- Block application time(intraoperative)
- Sensory block onset time(5., 10., 15., 30. minutes)
- Motor block onset time(5., 10., 15., 30. minutes)
- Intraoperative additional analgesic/sedation consumption(intraoperative)
- Patient and surgeon satisfaction(end of surgery)
研究者
Korgün Ökmen
Principal Investigator.PhD.MD
Bursa Yuksek Ihtisas Training and Research Hospital