Standard Supraclavicular Block Versus Low-Volume Supraclavicular Block Plus Ulnar or Median Nerve Block for Hand Surgery in the Ulnar or Median Nerve Distribution
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Successful anesthesia, defined as no additional local anesthetic or heavy sedation required.
研究概览
简要总结
This study will examine how successfully nerves are blocked or frozen for hand surgery. Traditionally, the nerves are frozen at the base of the neck, just above the clavicle or collarbone (the supraclavicular block). This is mostly successful by itself, and provides anesthesia of the entire arm. Occasionally, an additional nerve block is required further down the arm, as the supraclavicular block may have missed a segment, or it is taking too long to come on. In this study the investigators will compare the traditional technique, with a similar but lower volume supraclavicular block plus an immediate low volume block of one nerve further down the arm (the ulnar or median nerve block, depending on which digits are being operated on). The investigators will compare success rates, speed of onset, procedural comfort and length of time of weakness and numbness, plus any adverse events.
详细描述
Background
Regional anesthesia is commonly employed for surgery on the hand. It is well tolerated by most patients and has a high safety record.
The most common form of regional anesthesia for this surgery is the supraclavicular block which is successful in most cases. Occasionally an additional nerve block and/or moderate sedation is required. The most frequent additional nerve blocks required are for the ulnar and median nerves.
This study aims to address whether a low volume supraclavicular block plus a selective ulnar or median nerve block reduces the time taken for onset of anesthesia, reduces the time of post-operative complete limb immobility, improves the surgical success of the block, and increases patient satisfaction, compared to a standard block.
The study will be powered to detect a 25% difference in successful surgical anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Surgery on distal upper extremity amenable to a regional anesthetic involving the ulnar (ring, pinky fingers) or median (thumb, index, middle fingers) distribution.
排除标准
- •Patient refusal
- •Allergy to amide local anesthetics
- •Severe coagulopathy
- •Bilateral upper limb surgery
- •Surgery involving bone graft from the iliac crest
- •Request for general anesthetic from surgical or research team (for example, nerve stimulation studies)
结局指标
主要结局
Successful anesthesia, defined as no additional local anesthetic or heavy sedation required.
时间窗: From injection of local anesthetic to suitable nerve blockade for surgery; approximately 20 minutes
Successful anesthesia will be determined by assessing the nerve block(s) following injection of local anesthetic, and deeming the block sufficient enough for surgery to proceed without any need for additional local anesthetic or heavy sedation. The period between the initial injection and successful anesthesia is approximately 20 minutes, depending on the patient.
次要结局
- Duration of analgesia(Approximately 6 hours)
- Time to successful anesthetic block from withdrawal of final needle(Approximately 20 minutes)
- Time for procedure, from placement of probe on skin to withdrawal of needle(Approximately 30 minutes)
- Duration of motor blockade(Approximately one hour)
- Patient satisfaction(24-48 hours)